drugset / Trial / NCT01033760
Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)
Phase 3
Completed
90 enrolled
ANRS, Emerging Infectious Diseases
Gilead Sciences · collabJanssen-Cilag Ltd. · collabMerck Sharp & Dohme LLC · collabPfizer · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this trial is to assess the impact of raltegravir, maraviroc, darunavir/r, and Truvada® (emtricitabine/tenofovir) vs. darunavir/r and Truvada® on cell-associated HIV-DNA levels in patients with primary HIV-1 infection.
Timeline
- Start
- 2010-04
- Primary completion
- 2013-07
- Completion
- 2013-12
Outcome
Missed primary endpoint
paper 2·35 [IQR 2·05-2·50] log₁₀ per 10(6) PBMC in the intensive cART group vs 2·25 [1·71-2·55] in the standard cART group; p=0·21). PMID 25701561 ↗
paper cART intensified with raltegravir and maraviroc did not have a greater effect on HIV blood reservoirs than did standard cART. PMID 25701561 ↗
Publications
- Cheret A, Durier C, Melard A, Ploquin M, Heitzmann J, Lecuroux C, Avettand-Fenoel V, David L, Pialoux G, Chennebault JM, Muller-Trutwin M, Goujard C, Rouzioux C, Meyer L; ANRS OPTIPRIM study group. Impact of early cART on HIV blood and semen compartments at the time of primary infection. PLoS One. 2017 Jul 14;12(7):e0180191. doi: 10.1371/journal.pone.0180191. eCollection 2017.
- Cheret A, Nembot G, Melard A, Lascoux C, Slama L, Miailhes P, Yeni P, Abel S, Avettand-Fenoel V, Venet A, Chaix ML, Molina JM, Katlama C, Goujard C, Tamalet C, Raffi F, Lafeuillade A, Reynes J, Ravaux I, Hoen B, Delfraissy JF, Meyer L, Rouzioux C; OPTIPRIM ANRS Study Group. Intensive five-drug antiretroviral therapy regimen versus standard triple-drug therapy during primary HIV-1 infection (OPTIPRIM-ANRS 147): a randomised, open-label, phase 3 trial. Lancet Infect Dis. 2015 Apr;15(4):387-96. doi: 10.1016/S1473-3099(15)70021-6. Epub 2015 Feb 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Maraviroc | Other / unclassified | 150 mg | — |
| Subject | Raltegravir | Other / unclassified | 400 mg | — |
| Background | Darunavir | Small molecule | 800 mg | — |
| Background | Ritonavir | Other / unclassified | 100 mg | — |
| Background | Tenofovir | Small molecule | 245 mg | — |
| Background | emtricitabine | Other / unclassified | 200 mg | — |