Trials / Completed
CompletedNCT01033760
Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)
Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- ANRS, Emerging Infectious Diseases · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Primary HIV-1 infection is characterized by a phase of intense replication, with a quick dissemination and early changes in the immune system. During primary HIV-1 infection, damages to MALT and GALT promotes a chronic cell activation, which participates in a progressive decay of immune functions. After HAART initiation, the magnitude and rapidity of cell-associated HIV-DNA decrease are significantly higher in patients with primary HIV-1 infection than in patients with chronic infection (Ngo Giang Huong, AIDS 2004). We hypothesize that an early intervention at different levels of viral replication with potent and well-tolerated new drugs may have a greater impact on cell-associated HIV-DNA levels than conventional triple-drug HAART.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine | raltegravir (Isentress®): 400 mg bid. maraviroc (Celsentri®): 150 mg bid. darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD. |
| DRUG | darunavir; ritonavir; emtricitabine/tenofovir | darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD. |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2013-07-01
- Completion
- 2013-12-01
- First posted
- 2009-12-16
- Last updated
- 2014-02-05
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT01033760. Inclusion in this directory is not an endorsement.