NCT02671383 (DRV) is a Phase 3 clinical trial of Darunavir in HIV Infections, sponsored by Willem Daniel Francois Venter.

Who is sponsoring NCT02671383?

NCT02671383 is sponsored by Willem Daniel Francois Venter.

What drugs are being tested in NCT02671383?

Interventions in NCT02671383: Darunavir, Lopinavir.

What condition does NCT02671383 study?

NCT02671383 studies HIV Infections.

Is NCT02671383 still recruiting?

NCT02671383 is currently completed. Last updated 26 June 2018.

Last reviewed 2018-06-26 · How we verify

NCT02671383: DRV

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

Evaluation of Low-dose Darunavir in a Switch Study

Completed Phase 3 Last updated 26 June 2018

What this trial tests

Phase 3 trial testing Darunavir in HIV Infections in 300 participants. Completed in 16 May 2018.

Timeline

30 June 2016

Primary endpoint
16 May 2018

16 May 2018

Quick facts

Lead sponsor	Willem Daniel Francois Venter
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	30 June 2016
Primary completion	16 May 2018
Estimated completion	16 May 2018
Sites	1 location across South Africa

Drugs / interventions tested

Darunavir (DARUNAVIR) — full drug profile →
Lopinavir (LOPINAVIR) — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

Willem Daniel Francois Venter

Who can join

Adults 18 to 100, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a switch study to assess the non-inferiority (in terms of efficacy and safety) of darunavir (boosted with ritonavir, DRV/r 400mg/100mg daily) when compared with lopinavir (boosted with ritonavir, LPV/r total dose 800mg/200mg daily), in combination with a nucleoside backbone, administered as a second line therapy in HIV positive individuals.

Publications & conference data

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

Low-dose ritonavir-boosted darunavir once daily versus ritonavir-boosted lopinavir for participants with less than 50 HIV RNA copies per mL (WRHI 052): a randomised, open-label, phase 3, non-inferiority trial.
Venter WDF, Moorhouse M, Sokhela S, Serenata C, et al · · 2019 · cited 13× · PMID 31202690 · DOI 10.1016/s2352-3018(19)30081-5
Phone Calls to Retain Research Participants and Determinants of Reachability in an African Setting: Observational Study.
Draaijer M, Lalla-Edward ST, Venter WDF, Vos A. · · 2020 · cited 5× · PMID 32996891 · DOI 10.2196/19138
Quality of life and associated factors among people receiving second-line anti-retroviral therapy in Johannesburg, South Africa.
Mokgethi NO, Christofides N, Machisa M, Akpomiemie G, et al · · 2022 · cited 4× · PMID 35550020 · DOI 10.1186/s12879-022-07429-9

Verify or expand the search:

Other trials of Darunavir

Trials testing the same drug.

NCT04183738 — Inflammation and Co-Infections in D²EFT · Phase 4 · withdrawn
NCT04718805 — A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions · Phase 1 · completed
NCT04661397 — A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Prese · Phase 1 · completed
NCT04236453 — A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Prese · Phase 1 · terminated
NCT04208061 — A Study of Darunavir in Combination With Cobicistat or Ritonavir, and Dabigatran Etexilate in Healthy Participants · Phase 1 · completed

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · 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 NCT02671383 (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 Willem Daniel Francois Venter
Last refreshed: 26 June 2018

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/NCT02671383.

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