Study on Pharmacokinetics of newly developed ANtiretroviral agents in HIV-infected pregNAnt women (PANNA)

2024-515487-31-00 Protocol 103900 Therapeutic use (Phase IV) Ended

End 12 Dec 2025 · Status Ended · 5 EU/EEA countries · 16 sites · Protocol 103900

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ended
Participants planned 211
Countries 5
Sites 16

HIV-infected

The primary objective of this study is to describe the pharmacokinetics of antiretroviral agents for which no or only limited pharmacokinetic data during pregnancy are available, in the 3rd trimester of pregnant HIV-infected women and at post-partum. And in the 2nd trimester for raltegravir once-daily regimen and d…

Key facts

Sponsor
Stichting Radboud universitair medisch centrum
Participant type
Patients
Age range
18-64 years
Gender
Female
Therapeutic area
Diseases [C] - Virus Diseases [C02]
Trial duration
completed 12 Dec 2025
Decision date (initial)
2024-10-21
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2024-515487-31-00
EudraCT number
2008-006158-16
ClinicalTrials.gov
NCT00825929

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Therapy

The primary objective of this study is to describe the pharmacokinetics of
antiretroviral agents for which no or only limited pharmacokinetic data during
pregnancy are available, in the 3rd trimester of pregnant HIV-infected
women and at post-partum. And in the 2nd trimester for raltegravir once-daily
regimen and dolutegravir regimen.
In addition, the pharmacokinetics will be determined in the infant as well in
case of post-exposure prophylaxis with one of the agents tested (not
performed in Germany).

Secondary objectives 3

  1. Secondary objective of this study is to describe the safety of the antiretroviral agents during pregnancy and the efficacy in terms of viral load response of the mother and prevention of mother to child transmission.
  2. To describe breastmilk transfer in case of breastfeeding and exposure in child if breastfeeding.
  3. For the raltegravir once-daily regimen the following additional objectives apply: To describe pharmacokinetics in the infant after birth a time point of blood sampling for regular care (not performed in Germany). To describe the safety of the antiretroviral agents, in this case specifically the reformulated once-daily raltegravir tablets, during pregnancy and the efficacy in terms of viral load response of the mother and prevention of mother to child transmission. To investigate the relation between progesterone levels and raltegravir pharmacokinetic changes in pregnancy. For the cabotegravir/rilpivirine LA regimen, the following additional objectives apply: To describe pharmacokinetics over the duration of pregnancy by trough samples prior to each injection. To describe pharmacokinetics in the infant after birth a time point of blood sampling for regular care. To describe breastmilk transfer in case of breastfeeding for cabotegravir/rilpivirine and exposure in child if breastfeeding.

Conditions and MedDRA coding

HIV-infected

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. HIV-infected as documented by positive HIV antibody test and confirmed by an antigen test.
  2. Subject is at least 18 years of age at screening.
  3. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
  4. Treated with a cART regimen containing at least one agent which is mentioned in Appendix 1; this agent has been taken for at least 2 weeks before the day of first PK curve evaluation.
  5. Subject is pregnant.
  6. Subject is able to adhere to food intake recommendations, if applicable.

Exclusion criteria 4

  1. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
  2. Inability to understand the nature and extent of the study and the procedures required.
  3. Presence of grade III/IV anemia (i.e. Hb <4.6 mmol/L or <7.4 g/dL).
  4. Using oral cabotegravir/rilpivirine.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

  1. AUC0-tau; Cmax; Ctrough, tmax, thalf for pregnant women. Comparison between these parameters during pregnancy and the parameters after pregnancy using mixed model analysis .
  2. Ctrough in pregnancy should be above the minimal effective plasma concentration.
  3. Cord blood/maternal blood concentration ratio at delivery.
  4. Determination of half life in infants after in utero exposure if applicable (washout half life).
  5. Breastmilk/maternal plasma ratio in case of breastfeeding and exposure in child if breastfeeding.

Secondary endpoints 3

  1. Description of maternal viral suppression during pregnancy and postpartum.
  2. Description of infection status of infants at birth.
  3. Description of SAEs and AEs reported during pregnancy and postpartum.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 32

Ziagen 300 mg film-coated tablets

PRD2133512 · Product

Active substance
Abacavir Sulfate
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
600 mg milligram(s)
Max total dose
196 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AF06 — ABACAVIR
Marketing authorisation
EU/1/99/112/001
MA holder
VIIV HEALTHCARE B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ritonavir Accord 100 mg filmomhulde tabletten

PRD10416912 · Product

Active substance
Ritonavir
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
200 mg milligram(s)
Max total dose
196 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AE03 — RITONAVIR
Marketing authorisation
RVG 115126
MA holder
ACCORD HEALTHCARE B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

STOCRIN 600 mg film-coated tablets

PRD6283738 · Product

Active substance
Efavirenz
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
600 mg milligram(s)
Max total dose
98 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AG03 — EFAVIRENZ
Marketing authorisation
EU/1/99/111/008
MA holder
MERCK SHARP & DOHME B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Eviplera 200 mg/25 mg/245 mg film-coated tablets

PRD298715 · Product

Active substance
Emtricitabine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1 U unit(s)
Max total dose
98 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AR08 — -
Marketing authorisation
EU/1/11/737/002
MA holder
GILEAD SCIENCES IRELAND UNLIMITED COMPANY
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pifeltro 100 mg film-coated tablets

PRD6790340 · Product

Active substance
Doravirine
Substance synonyms
MK-1439
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
100 mg milligram(s)
Max total dose
98 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AG06 — -
Marketing authorisation
EU/1/18/1332/001
MA holder
MERCK SHARP & DOHME B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

EDURANT 25 mg film-coated tablets

PRD3349053 · Product

Active substance
Rilpivirine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
25 mg milligram(s)
Max total dose
98 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AG05 — -
Marketing authorisation
EU/1/11/736/001
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

ISENTRESS 400 mg film-coated tablets

PRD6356266 · Product

Active substance
Raltegravir
Substance synonyms
MK-0518
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
800 mg milligram(s)
Max total dose
196 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AJ01 — -
Marketing authorisation
EU/1/07/436/001
MA holder
MERCK SHARP & DOHME B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fuzeon 90 mg/ml powder and solvent for solution for injection

PRD2153971 · Product

Active substance
Enfuvirtide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
180 mg milligram(s)
Max total dose
196 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AX07 — -
Marketing authorisation
EU/1/03/252/001
MA holder
ROCHE REGISTRATION GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Descovy 200 mg/10 mg film-coated tablets

PRD4052392 · Product

Active substance
Emtricitabine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1 U unit(s)
Max total dose
98 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AR17 — -
Marketing authorisation
EU/1/16/1099/001
MA holder
GILEAD SCIENCES IRELAND UNLIMITED COMPANY
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

TRIZIVIR 300 mg/150 mg/300 mg film-coated tablets

PRD2134007 · Product

Active substance
Zidovudine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
2 U unit(s)
Max total dose
196 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AR04 — -
Marketing authorisation
EU/1/00/156/002
MA holder
VIIV HEALTHCARE B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

REKAMBYS 900 mg prolonged-release suspension for injection

PRD8603225 · Product

Active substance
Rilpivirine
Pharmaceutical form
PROLONGED-RELEASE SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
20 mg milligram(s)
Max total dose
10 U unit(s)
Max treatment duration
15 Month(s)
Authorisation status
Authorised
ATC code
J05AG05 — -
Marketing authorisation
EU/1/20/1482/002
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

REYATAZ 300 mg hard capsules

PRD2333429 · Product

Active substance
Atazanavir
Substance synonyms
BMS232632, ATV
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
1 U unit(s)
Max total dose
98 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AE08 — -
Marketing authorisation
EU/1/03/267/009
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kivexa 600 mg/300 mg film-coated tablets

PRD2134003 · Product

Active substance
Abacavir Sulfate
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
2 U unit(s)
Max total dose
196 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AR02 — -
Marketing authorisation
EU/1/04/298/002
MA holder
VIIV HEALTHCARE B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vocabria 600 mg prolonged-release suspension for injection

PRD8594142 · Product

Active substance
Cabotegravir
Substance synonyms
(3S,11AR)-N-((2,4-DIFLUOROPHENYL)METHYL)-6-HYDROXY-3-METHYL-5,7-DIOXO-2,3,5,7,11,11A-HEXAHYDROOXAZOLO(3,2-A)PYRIDO(1,2-D)PYRAZINE-8-CARBOXAMIDE, GSK1265744
Pharmaceutical form
PROLONGED-RELEASE SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
20 mg milligram(s)
Max total dose
15 U unit(s)
Max treatment duration
15 Month(s)
Authorisation status
Authorised
ATC code
J05AJ04 — -
Marketing authorisation
EU/1/20/1481/003
MA holder
VIIV HEALTHCARE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

REKAMBYS 600 mg prolonged-release suspension for injection

PRD8603221 · Product

Active substance
Rilpivirine
Pharmaceutical form
PROLONGED-RELEASE SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
20 mg milligram(s)
Max total dose
15 U unit(s)
Max treatment duration
15 Month(s)
Authorisation status
Authorised
ATC code
J05AG05 — -
Marketing authorisation
EU/1/20/1482/001
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Truvada 200 mg/245 mg film-coated tablets

PRD293463 · Product

Active substance
Emtricitabine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1 U unit(s)
Max total dose
98 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AR03 — -
Marketing authorisation
EU/1/04/305/001
MA holder
GILEAD SCIENCES IRELAND UNLIMITED COMPANY
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Norvir 100 mg film-coated tablets

PRD6198800 · Product

Active substance
Ritonavir
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
2 U unit(s)
Max total dose
196 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AE03 — RITONAVIR
Marketing authorisation
EU/1/96/016/005
MA holder
ABBVIE DEUTSCHLAND GMBH & CO. KG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Viread 245 mg film-coated tablets

PRD294853 · Product

Active substance
Tenofovir Disoproxil
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
245 mg milligram(s)
Max total dose
98 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AF07 — TENOFOVIR DISOPROXIL
Marketing authorisation
EU/1/01/200/002
MA holder
GILEAD SCIENCES IRELAND UNLIMITED COMPANY
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Aptivus 250 mg soft capsules

PRD295288 · Product

Active substance
Tipranavir
Pharmaceutical form
CAPSULE, SOFT
Route of administration
ORAL
Max daily dose
1000 mg milligram(s)
Max total dose
392 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AE09 — -
Marketing authorisation
EU/1/05/315/001
MA holder
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

INTELENCE 100 mg tablets

PRD3353108 · Product

Active substance
Etravirine
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
4 U unit(s)
Max total dose
392 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AG04 — -
Marketing authorisation
EU/1/08/468/001
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

CELSENTRI 150 mg film-coated tablets

PRD2135547 · Product

Active substance
Maraviroc
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
600 mg milligram(s)
Max total dose
392 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AX09 — -
Marketing authorisation
EU/1/07/418/001
MA holder
VIIV HEALTHCARE B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Biktarvy 50 mg/200 mg/25 mg film-coated tablets

PRD6357588 · Product

Active substance
Emtricitabine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1 U unit(s)
Max total dose
98 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AR20 — -
Marketing authorisation
EU/1/18/1289/001
MA holder
GILEAD SCIENCES IRELAND UNLIMITED COMPANY
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Telzir 700 mg film-coated tablets

PRD2134017 · Product

Active substance
Fosamprenavir Calcium
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1400 mg milligram(s)
Max total dose
196 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AE07 — -
Marketing authorisation
EU/1/04/282/001
MA holder
VIIV HEALTHCARE B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Emtriva 200 mg hard capsules

PRD301848 · Product

Active substance
Emtricitabine
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
200 mg milligram(s)
Max total dose
98 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AF09 — -
Marketing authorisation
EU/1/03/261/001
MA holder
GILEAD SCIENCES IRELAND UNLIMITED COMPANY
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vocabria 400 mg prolonged-release suspension for injection

PRD8594098 · Product

Active substance
Cabotegravir
Substance synonyms
(3S,11AR)-N-((2,4-DIFLUOROPHENYL)METHYL)-6-HYDROXY-3-METHYL-5,7-DIOXO-2,3,5,7,11,11A-HEXAHYDROOXAZOLO(3,2-A)PYRIDO(1,2-D)PYRAZINE-8-CARBOXAMIDE, GSK1265744
Pharmaceutical form
PROLONGED-RELEASE SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
20 mg milligram(s)
Max total dose
22 U unit(s)
Max treatment duration
15 Month(s)
Authorisation status
Authorised
ATC code
J05AJ04 — -
Marketing authorisation
EU/1/20/1481/002
MA holder
VIIV HEALTHCARE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tivicay 50 mg film-coated tablets

PRD6421418 · Product

Active substance
Dolutegravir Sodium
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
50 mg milligram(s)
Max total dose
182 U unit(s)
Max treatment duration
26 Week(s)
Authorisation status
Authorised
ATC code
J05AJ03 — -
Marketing authorisation
EU/1/13/892/001
MA holder
VIIV HEALTHCARE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

ISENTRESS 600 mg film-coated tablets

PRD6356270 · Product

Active substance
Raltegravir
Substance synonyms
MK-0518
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1200 mg milligram(s)
Max total dose
364 U unit(s)
Max treatment duration
26 Week(s)
Authorisation status
Authorised
ATC code
J05AJ01 — -
Marketing authorisation
EU/1/07/436/006
MA holder
MERCK SHARP & DOHME B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Descovy 200 mg/25 mg film-coated tablets

PRD4052394 · Product

Active substance
Emtricitabine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1 U unit(s)
Max total dose
98 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AR17 — -
Marketing authorisation
EU/1/16/1099/003
MA holder
GILEAD SCIENCES IRELAND UNLIMITED COMPANY
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Odefsey 200 mg/25 mg/25 mg film-coated tablets

PRD4191976 · Product

Active substance
Emtricitabine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1 U unit(s)
Max total dose
98 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AR19 — -
Marketing authorisation
EU/1/16/1112/001
MA holder
GILEAD SCIENCES IRELAND UNLIMITED COMPANY
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

INTELENCE 200 mg tablets

PRD3349052 · Product

Active substance
Etravirine
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
400 mg milligram(s)
Max total dose
196 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AG04 — -
Marketing authorisation
EU/1/08/468/002
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

CELSENTRI 300 mg film-coated tablets

PRD2135557 · Product

Active substance
Maraviroc
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
600 mg milligram(s)
Max total dose
196 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AX09 — -
Marketing authorisation
EU/1/07/418/006
MA holder
VIIV HEALTHCARE B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Delstrigo 100 mg/300 mg/245 mg film-coated tablets

PRD6778264 · Product

Active substance
Lamivudine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1 U unit(s)
Max total dose
98 U unit(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
J05AR24 — -
Marketing authorisation
EU/1/18/1333/001
MA holder
MERCK SHARP & DOHME B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Radboud universitair medisch centrum

24 Total trials 12 Recruiting 7 Ended
Academic / Non-commercial
Sponsor organisation
Stichting Radboud universitair medisch centrum
Address
Geert Grooteplein Zuid 10
City
Nijmegen
Postcode
6525 GA
Country
Netherlands

Scientific contact point

Organisation
Stichting Radboud universitair medisch centrum
Contact name
Angela Colbers

Public contact point

Organisation
Stichting Radboud universitair medisch centrum
Contact name
Angela Colbers

Locations

5 EU/EEA countries · 16 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ended 53 1
Germany Ended 38 5
Ireland Ended 11 2
Netherlands Ended 17 6
Spain Ended 44 2
Rest of world
United Kingdom, Aruba
 — 48 —

Investigational sites

Belgium

1 site · Ended
CHU Saint Pierre
Department of Infectious Disease, Hoogstraat 322, 1000, Brussels

Germany

5 sites · Ended
Klinikum der Universitaet Muenchen AöR
First Department of Obstetrics and Gynaecology, Ziemssenstrasse 5, 80336, Munich
Charite Universitaetsmedizin Berlin KöR
Klinik für Geburtsmedizin, Chariteplatz 1, Mitte, Berlin
Universitaetsklinikum Bonn AöR
HIV Outpatient Clinic, Robert-Koch-Strasse 1, Venusberg, Bonn
University Of Cologne
Department of Internal Medicine, Albertus-Magnus-Platz 1, 50923, Cologne
Goethe University Frankfurt
HIVcenter, Max-Von-Laue-Strasse 9, Kalbach, Frankfurt Am Main

Ireland

2 sites · Ended
St James's Hospital
Department of Genito Urinary Medicine and Infectious Diseases, James's Street, D08 NHY1, Dublin 8
Mater Misericordiae University Hospital
nfectious diseases and genitourinary medicine, Eccles Street, D07 R2WY, Dublin 7

Netherlands

6 sites · Ended
Universitair Medisch Centrum Groningen
Infectious Diseases Department, Hanzeplein 1, 9713 GZ, Groningen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Internal medicine, Infectious disease, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Stichting Elisabeth-Tweesteden Ziekenhuis
Internal medicine, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Radboud universitair medisch centrum Stichting
Internal medicine, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Amsterdam UMC Stichting
Internal medicine, Meibergdreef 9, 1105 AZ, Amsterdam
Universitair Medisch Centrum Utrecht
Internal medicine, Heidelberglaan 100, 3584 CX, Utrecht

Spain

2 sites · Ended
Hospital Universitario Virgen De Las Nieves
Department of Infectious Diseases, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Germans Trias I Pujol
Infectious Diseases Department, Carretera Canyet 1a Planta, 08916, Badalona

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 55 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2024-515487-31-00_ version 8_redacted 8
Recruitment arrangements (for publication) K1_Recruitment arrangements_Blank document 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_Blank document 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_Blank document 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_Blank document 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_Blank document 1
Subject information and informed consent form (for publication) L1_SIS_and_ICF_HIP_CAB-RPV_PANNA_Redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_HIP_Madre_PANNA_Redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_HIP_Menor_CAB-RPV_PANNA_Redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_HIP_subestudioRAL_menor_redacted 2
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA Patient Information Dutch CAB_RPV_redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA Patient Information Dutch_redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA Patient Information_add_RAL_substudy_infant Dutch_redacted 2
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA Patient Information_BEL_EN_redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA Patient Information_BEL_FR_redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA Patient Information_BEL_RAL_substudy_infant_FR_redacted 2
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA Patient Information_CAB_RPV_LA_EN_redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA Patient Information_CAB_RPV_LA_FR_redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA Patient Information_CAB_RPV_substudy_infant_FR_breastfed_redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA Patient Information_CAB_RPV_substudy_infant_FR_redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA Patient Information_CAB_RPV_substudy_infant_IE_breastfed_Redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA Patient Information_CAB_RPV_substudy_infant_IE_Redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA Patient Information_CAB_RPV_substudy_infant_NED_borstvoeding_redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA Patient Information_CAB_RPV_substudy_infant_NED_redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA Patient Information_RAL_substudy_infant_EN_redacted 2
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA PIL CAB_RPV LA_Redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA PIL_Redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA_Pat_info_CAB_RPV_Ger_redacted 8
Subject information and informed consent form (for publication) L1_SIS_and_ICF_PANNA_Pat_info_incl_Ger_redacted 8
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Abacavir 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC abacavir-lamivudine 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Atazanavir 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bictegravir-FTC-TAF 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Cabotegravir 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Dolutegravir 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC doravirine 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC doravirine-3TC-TDF 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Efavirenz 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Emtricitabine 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Emtricitabine-tenofovir alafenamide 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Emtricitabine-tenofovir disoproxil 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Enfuvirtide 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Etravirine 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC EVG-COBI-FTC-TAF 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Fosamprenavir 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Maraviroc 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Raltegravir 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Rilpivirine LA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Rilpivirine ORAL 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Ritonavir 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC RPV-emtricitabine-TDF 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC RPV-FTC-TAF 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Tenofovir Disoproxil 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Tipranavir 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC zidovudine-lamivudine-abacavir 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-09-18 Netherlands Acceptable with conditions
2024-10-16
 2024-10-16

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