Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT02770508
Brief 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)
Study:
NCT02770508
Study Brief:
Protocol Section:
NCT02770508