Darunavir/Ritonavir + Lamivudine Versus Darunavir/Ritonavir +Emtricitabine/Tenofovir in Naïve HIV-1 Infected Subjects (ANDES)
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|ClinicalTrials.gov Identifier: NCT02770508|
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : August 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV-1 Infection||Drug: darunavir/ritonavir Drug: Lamivudine Drug: emtricitabine-tenofovir(FTC/TDF)||Phase 4|
Key Inclusion Criteria
- Documented HIV RNA >1000 copies/ml
- Subject naïve to ARV. .
- Subject has indication to receive an antiretroviral regimen, based on local guidelines.
- Able to provide informed consent and agree to use a highly effective non-hormonal method of contraception
Key Exclusion Criteria
- Evidence of resistance to Darunavir and/or FTC or 3TC or TDF based on the resistance test
- Patient with chronic hepatitis B
- Subject has a currently active AIDS defining illness (Category C conditions according to the CDC Classification System
- Required use of disallowed concomitant therapies
- Subject with the grade 3 or 4 laboratory abnormalities as defined by DAIDS grading table
• Proportion of patients with HIV-1 RNA levels of less than 50 copies/mL at week 48 (ITT analysis, Snapshot analysis)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||145 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||October 2017|
Experimental: Darunavir/ritonavir plus lamivudine
Darunavir/ritonavir 800/100 mg, 1 coformulated tablet QD and lamivudine 300 mg, 1 tablet QD
Other Name: Virontar R
Other Name: 3TC
Active Comparator: Darunavir/ritonavir plus emtricitabine/tenofovir(FTC/TFD)
Darunavir/ritonavir 800/100 mg1 coformulated tablet QD (FDC) plus FTC/TDF 200/300 mg, 1 coformulated tablet QD
Other Name: Virontar R
Other Name: TRUVADA
- Percentage of patients with HIV-1 RNA levels of less than 50 copies/mL at week 48 [ Time Frame: 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).
- Percentage of patients with HIV-1 RNA <400 copies/mL at week 24 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: week 24 and 48 ]Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
- Clinical disease progression (CDP) [ Time Frame: 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 [ Time Frame: 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 .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770508
|Consultorio Infectológico Dr. Pryluka|
|Caba, Buenos Aires, Argentina, 1121|
|Hospital Cosme Argerich|
|Caba, Buenos Aires, Argentina, 1155ADP|
|Caba, Buenos Aires, Argentina, 1199ABB|
|Caba, Buenos Aires, Argentina, C1202ABB|
|Centro de Estudios Infectologicos SA (CTD Stamboulian)|
|Caba, Buenos Aires, Argentina, C1425AWK|
|Principal Investigator:||Pedro Cahn, PhD, MD||Fundacion Huesped|