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NCT02987530: OPTIPRIM-2
National Multicenter Trial Evaluating Two Treatments in Patients With Primary Human Immunodeficiency Virus (HIV-1) Infection
Phase 3 trial testing Dolutegravir in HIV-1 Infection in 101 participants. Completed in 31 January 2020.
30 July 2019
Quick facts
| Lead sponsor | ANRS, Emerging Infectious Diseases |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 101 |
| Start date | 11 April 2017 |
| Primary completion | 30 July 2019 |
| Estimated completion | 31 January 2020 |
| Sites | 1 location across France |
Drugs / interventions tested
- Dolutegravir (DOLUTEGRAVIR) — full drug profile →
- Darunavir-cobicistat
- Emtricitabine-Tenofovir
Conditions studied
- HIV-1 Infection — all drugs for HIV-1 Infection →
Sponsor
ANRS, Emerging Infectious Diseases — full company profile →
Who can join
18 and older, any sex, with HIV-1 Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to compare the impact of two combination of two tablets once daily: dolutegravir associated with emtricitabine / tenofovir versus darunavir / cobicistat associated with emtricitabine / tenofovir on DNA HIV measured in PBMC at 48 weeks in patients with primary HIV-1 infection.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Accuracy of measures for antiretroviral adherence in people living with HIV.
Smith R, Villanueva G, Probyn K, Sguassero Y, et al · · 2022 · cited 34× · PMID 35871531 · DOI 10.1002/14651858.cd013080.pub2
Verify or expand the search:
- PubMed search for NCT02987530
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Dolutegravir
Trials testing the same drug.
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- NCT05652478 — Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study · Phase 2 · recruiting
- NCT06805656 — Multi Interventional Approaches to Mitigate HIV Reservoirs Aiming the Sustained HIV Remission Without Antiretrovirals · Phase 2 · not yet recruiting
- NCT05979311 — A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Ora · Phase 3 · active not recruiting
Other recruiting trials for HIV-1 Infection
Currently open trials in the same condition.
- NCT06660498 — Pomalidomide as an Immune-enhancing Agent for the Control of HIV · Phase 1, PHASE2 · recruiting
- NCT06602622 — Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI · Phase 4 · recruiting
- NCT05705349 — DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053) · Phase 3 · active not recruiting
- NCT05631093 — A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Vir · Phase 3 · active not recruiting
- NCT05630755 — A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Vir · Phase 3 · active not recruiting
Other ANRS, Emerging Infectious Diseases trials
Trials by the same sponsor.
- NCT07098481 — Access to Hepatitis C Treatment in Cameroon: Comparison of a Simplified Test and Treat Strategy to a Standard Strategy · Phase 4 · not yet recruiting
- NCT06913959 — HIV-1 Non-group M in Cameroon : Study of Genotypic and Phylogenetic Diversity (OBSOCAM) · not yet recruiting
- NCT07113106 — Dose Escalation Trial of CD40.Pan.CoV Vaccine, Adjuvanted or Not, as a Booster in Adult Healthy Volunteers · Phase 1, PHASE2 · recruiting
- NCT05222945 — A Study to Determine the Cartography of Virologic Reservoir Related to Antiretroviral Concentrations in HIV-1 Chronic Pa · NA · not yet recruiting
- NCT06522256 — Identification of Molecular Signatures of High-risk Oncogenic HPV and Study of Their Associations With the Presence of H · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02987530 (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 ANRS, Emerging Infectious Diseases
- Last refreshed: 7 April 2026
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/NCT02987530.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing