NCT02993237 is a Phase 1 clinical trial of DRV/COBI FDC placebo tablet in HIV-1, sponsored by Janssen Research & Development, LLC.

Who is sponsoring NCT02993237?

NCT02993237 is sponsored by Janssen Research & Development, LLC.

What drugs are being tested in NCT02993237?

Interventions in NCT02993237: DRV/COBI FDC placebo tablet, D/C/F/TAF FDC placebo tablets.

Is NCT02993237 still recruiting?

NCT02993237 is currently completed. Last updated 13 May 2019.

Last reviewed 2019-05-13 · How we verify

NCT02993237

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Assess the Acceptability/Swallowability of DRV-Containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets

Completed Phase 1 Last updated 13 May 2019

What this trial tests

Phase 1 trial testing DRV/COBI FDC placebo tablet in HIV-1 in 27 participants. Completed in 25 May 2017.

Timeline

23 January 2017

Primary endpoint
25 May 2017

25 May 2017

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	27
Start date	23 January 2017
Primary completion	25 May 2017
Estimated completion	25 May 2017
Sites	4 locations across United States

Drugs / interventions tested

DRV/COBI FDC placebo tablet
D/C/F/TAF FDC placebo tablets — full drug profile →

Conditions studied

HIV-1 — all drugs for HIV-1 →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

Adults 12 to 17, any sex, with HIV-1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of this study is to assess the acceptability of swallowing the darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets, using matching placebo tablets, in human immunodeficiency virus (HIV) -1 infected adolescent patients.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

HIV Glasgow 2018, 28-31 October 2018, Glasgow, UK.
· 2018 · cited 7× · PMID 30362663 · DOI 10.1002/jia2.25187
Towards an ideal antiretroviral regimen for the global HIV epidemic.
Grinsztejn B, Coelho LE, Luz PM, Veloso VG. · · 2017 · cited 1× · PMID 28758017 · DOI 10.1016/s2055-6640(20)30328-9

Verify or expand the search:

Other recruiting trials for HIV-1

Currently open trials in the same condition.

NCT06517693 — Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1 · Phase 1 · recruiting
NCT06252402 — CMV-specific HIV-CAR T Cells as Immunotherapy for HIV/AIDS · EARLY_PHASE1 · recruiting
NCT05612178 — A Study to Evaluate the Safety and Effects of Repeated Doses of 3BNC117-LS and 10-1074-LS on Persistent Viral Reservoirs · Phase 1 · active not recruiting
NCT00980538 — TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants · Phase 3 · active not recruiting

Other Janssen Research & Development, LLC trials

Trials by the same sponsor.

NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02993237 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
Last refreshed: 13 May 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02993237.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing