NCT02987530

National Multicenter Trial Evaluating Two Treatments in Patients With Primary Human Immunodeficiency Virus (HIV-1) Infection

Phase III Multicenter Randomized Trial Evaluating in Patients at the Time of the Primary HIV-1 Infection, the Impact on the Viral Reservoir of a Combination Including Tenofovir/Emtricitabine and Dolutegravir or Tenofovir/Emtricitabine and Darunavir/Cobicistat

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Phase III, randomized (1: 1), comparative, superiority, open-label, parallel assignment, national multicenter trial evaluating two treatments in patients with primary HIV-1 infection. Comparison of the two combinations regarding: * Viral reservoir at W48 * Early inhibition of viral replication, * Plasmatic and cellular cumulative viremia at W48, * Immune reconstitution with CD4, CD8 levels and CD4 / CD8 ratio, * Activation parameters decrease, * Adherence to treatments, * Treatments tolerance, * Adverse events, * Quality of life (by self-administered questionnaires). Study of the pharmacokinetics / dynamics relationship of the decay of plasma, cellular and spermatic compartments' viral loads. 50 participants per group will be enrolled in 40 sites in France. Co- inclusion in ANRS CO 06 PRIMO cohort will be offered

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	Dolutegravir	Oral use, 50mg/day
DRUG	Darunavir-cobicistat	Oral use, 800-150mg/day
DRUG	Emtricitabine-Tenofovir	Oral use, Emtricititabine : 200mg/day Ténofovir : 245mg

Timeline

• Start date: 2017-04-11
• Primary completion: 2019-07-30
• Completion: 2020-01-31
• First posted: 2016-12-09
• Last updated: 2026-04-07

Locations

1 site across 1 country: France