drugset / Trial / NCT01154673
Effects of Intensive cART During Acute/Early HIV Infection
Phase 2/3
Completed
32 enrolled
University of Toronto
Maple Leaf Research · collabUnity Health Toronto · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This trial will investigate the efficacy and safety of intensified antiretroviral treatment that includes raltegravir and maraviroc during the early stages of HIV infection. With the proven efficacy of these antiviral drugs in pre- and post-clinical trials, we would like to investigate the ability of the combination of raltegravir and maraviroc plus a standard HAART backbone to further decrease the viral load in acutely infected treated HIV infected individuals.
Timeline
- Start
- 2011-11
- Primary completion
- 2014-09
- Completion
- 2014-09
Outcome
Missed primary endpoint
registry Intensive HAART vs Placebo Arm; p = 0.056; Mean Difference (Final Values) 0.2 (95% CI -.006 to 0.4) NCT01154673 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Maraviroc | Other / unclassified | 150 mg | — |
| Subject | Raltegravir | Other / unclassified | 400 mg | — |
| Background | Lopinavir | Other / unclassified | 400 mg | — |
| Background | Ritonavir | Other / unclassified | 100 mg | — |
| Background | Tenofovir | Small molecule | 300 mg | — |
| Background | emtricitabine | Other / unclassified | 200 mg | — |
Indications
No indication recorded.