Darunavir/Ritonavir + Lamivudine Versus Darunavir/Ritonavir +Emtricitabine/Tenofovir in Naïve HIV-1 Infected Subjects
- Conditions
- HIV-1 Infection
- Interventions
- Registration Number
- NCT02770508
- Lead Sponsor
- Fundación Huésped
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Darunavir/ritonavir plus emtricitabine/tenofovir(FTC/TFD) darunavir/ritonavir Darunavir/ritonavir 800/100 mg1 coformulated tablet QD (FDC) plus FTC/TDF 200/300 mg, 1 coformulated tablet QD Darunavir/ritonavir plus lamivudine darunavir/ritonavir Darunavir/ritonavir 800/100 mg, 1 coformulated tablet QD and lamivudine 300 mg, 1 tablet QD Darunavir/ritonavir plus emtricitabine/tenofovir(FTC/TFD) emtricitabine-tenofovir(FTC/TDF) Darunavir/ritonavir 800/100 mg1 coformulated tablet QD (FDC) plus FTC/TDF 200/300 mg, 1 coformulated tablet QD Darunavir/ritonavir plus lamivudine Lamivudine Darunavir/ritonavir 800/100 mg, 1 coformulated tablet QD and lamivudine 300 mg, 1 tablet QD
- Primary Outcome Measures
Name Time Method Percentage of patients with HIV-1 RNA levels of less than 50 copies/mL at week 48 48 weeks The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) \<50 c/mL at Week 48 will be assessed using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm. This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, Otherwise, virologic success or failure will be determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks).
- Secondary Outcome Measures
Name Time Method Percentage of patients with HIV-1 RNA <400 copies/mL at week 24 24 weeks The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) \<400 c/mL at Week 24 will be assessed using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm.
Number and type of resistance mutations in case of virologic failure from week 24 to week 48 An genotiping test will be made at time to virological failure to detect mutation across reverse transcriptase (RT), and Protease (PRO). Protocol defined virological failure was defined as confirmed plasma HIV-1 RNA levels \>=400 copies/mL on or after Week 24 or confirmed plasma HIV-1 RNA levels \>=50 copies/mL at week 48
CD4+ lymphocyte count and change between baseline (defined as the average between screening and baseline visit values) and weeks 24 and 48 week 24 and 48 Change from Baseline in CD4+ cell counts will be assessed at Weeks 24 and 48.
Frequency, type and severity of adverse events and laboratory abnormalities. week 24 and 48 Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Clinical disease progression (CDP) week 24 and 48 Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.
Changes in quality of life baseline, week 24 and week 48 The evaluation of quality of life will be done through two validated instruments: the Medical Outcomes Study HIV Health Survey ( MOS - HIV) and EuroQol 5D (EQ - 5D ) . Both instruments will be administered to patients at baseline , week 24 and week 48 .
Trial Locations
- Locations (5)
Fundacion huesped
🇦🇷Caba, Buenos Aires, Argentina
Centro de Estudios Infectologicos SA (CTD Stamboulian)
🇦🇷Caba, Buenos Aires, Argentina
Consultorio Infectológico Dr. Pryluka
🇦🇷Caba, Buenos Aires, Argentina
Hospital Cosme Argerich
🇦🇷Caba, Buenos Aires, Argentina
Hospital Italiano
🇦🇷Caba, Buenos Aires, Argentina