NCT02770508

Darunavir/Ritonavir + Lamivudine Versus Darunavir/Ritonavir +Emtricitabine/Tenofovir in Naïve HIV-1 Infected Subjects

A Phase 4, Randomized, Open Label, Controlled Study of Boosted Darunavir and Lamivudine Versus Boosted Darunavir and Emtricitabine/Tenofovir or Lamivudine/Tenofovir in Naïve HIV-1 Infected Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Fundación Huésped · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and efficacy of a combination of a QD regimen consisting on ritonavir boosted darunavir (FDC) and lamivudine versus ritonavir boosted darunavir (FDC) plus co-formulated tenofovir and emtricitabine or co-formulated tenofovir/lamivudine in naïve HIV-1 infected patients. Subjects will be ARV-naïve HIV-1-infected patients eligible to start ARV therapy according to current guidelines.Subjects will be adults ≥ 18 years of age who meet all of the inclusion criteria and none of the exclusion criteria.

Detailed description

Key Inclusion Criteria 1. Documented HIV RNA \>1000 copies/ml 2. Subject naïve to ARV. . 3. Subject has indication to receive an antiretroviral regimen, based on local guidelines. 4. Able to provide informed consent and agree to use a highly effective non-hormonal method of contraception Key Exclusion Criteria 1. Evidence of resistance to Darunavir and/or FTC or 3TC or TDF based on the resistance test 2. Patient with chronic hepatitis B 3. Subject has a currently active AIDS defining illness (Category C conditions according to the CDC Classification System 4. Required use of disallowed concomitant therapies 5. Subject with the grade 3 or 4 laboratory abnormalities as defined by DAIDS grading table Primary Objective • Proportion of patients with HIV-1 RNA levels of less than 50 copies/mL at week 48 (ITT analysis, Snapshot analysis)

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	darunavir/ritonavir
DRUG	Lamivudine
DRUG	emtricitabine-tenofovir(FTC/TDF)

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-07-01
• Completion: 2017-10-01
• First posted: 2016-05-12
• Last updated: 2018-08-03

Locations

5 sites across 1 country: Argentina