HIV-1 Infection Clinical Trial
Official title:
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
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.
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)
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