SNPMiner Trials (Home Page)
Report for Mutation I50L
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 8 clinical trials
Clinical Trials
1 An Exploratory Study of the Effect of the Atazanavir (ATV) I50L Mutation on Subsequent Treatment Response
This study will compare the response of subjects who failed a first-line ATV-containing regimen and who have the 150L-containing virus to subsequent protease inhibitor (PI)-containing therapy with that of a cohort who has failed a first-line reverse transcriptase inhibitor (NNRTI), and is subsequently receiving PI-containing therapy.
NCT00096746 HIV Infection Drug: LPV/RTV + 2NRTIs Drug: LPV/RTV + 2NRTIs MeSH:HIV Infections
An Exploratory Study of the Effect of the Atazanavir (ATV) I50L Mutation on Subsequent Treatment Response. --- I50L ---
Primary Outcomes
Measure: The log10 HIV RNA change from baseline for each cohort. Time: through Week 48Secondary Outcomes
Measure: Evaluate proportion of patients with plasma HIV RNA <50 copies/mL Time: at Weeks 24, 48, 72, and 96.2 A Phase IV, Multicenter, Cross-sectional Study to Evaluate the I50L Substitution Among Subjects Experiencing Virologic Failure on a HAART Regimen Containing Atazanavir (ATV)
The purpose of this study is to find out the frequency of the I50L substitution among patients experiencing treatment failure on an atazanavir-containing regimen.
NCT00135447 HIV Infections MeSH:HIV Infections
A Phase IV, Multicenter, Cross-sectional Study to Evaluate the I50L Substitution Among Subjects Experiencing Virologic Failure on a HAART Regimen Containing Atazanavir (ATV). --- I50L ---
A Study of Prevalence of the I50L Mutation When ATV Treated Patients Fail the Regimen The purpose of this study is to find out the frequency of the I50L substitution among patients experiencing treatment failure on an atazanavir-containing regimen. --- I50L ---
A Study of Prevalence of the I50L Mutation When ATV Treated Patients Fail the Regimen The purpose of this study is to find out the frequency of the I50L substitution among patients experiencing treatment failure on an atazanavir-containing regimen. --- I50L --- --- I50L ---
3 Phase IIIb Multicenter, Single Arm, Open-Label Pilot Study to Evaluate the Effectiveness and Safety of Maintenance With Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in HIV-Infected Patients Evidencing Virologic Suppression OREY (Only REYataz) Study
The main purpose is to explore whether atazanavir/ritonavir (ATV/RTV) single enhanced protease inhibitor therapy can maintain virologic suppression without a marked increase in virologic failure.
NCT00337467 Human Immunodeficiency Virus (HIV) Infections Drug: Atazanavir + Ritonavir MeSH:Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes
HPO:Immunodeficiency
International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. --- V32I --- --- L33F --- --- M46I --- --- I47V --- --- G48V --- --- I50L ---
Primary Outcomes
Description: Treatment Failure through Week 48 defined as virologic rebound (HIV RNA >=400 c/mL) on or before Week 48 or study discontinuation before Week 48. Virological rebound is defined as confirmed on-treatment HIV ribonucleic acid (RNA) >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy.
Measure: Percentage of Participants With Treatment Failure Through Week 48 Time: Week 48Secondary Outcomes
Description: Treatment Failure through Week 96 defined as virologic rebound (HIV RNA >=400 c/mL) on or before Week 96 or study discontinuation before Week 96. In addition, treatment failure defined based on HIV RNA >= 50 c/mL, latter analysis performed on treated subjects with baseline HIV RNA < 50 c/mL.
Measure: Percentage of Participants With Treatment Failure Through Week 96 Time: Week 96Description: Virological rebound is defined as confirmed on-treatment HIV RNA >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA >=50 c/m, latter analysis performed on subjects with baseline HIV RNA < 50 c/mL.
Measure: Percentage of Participants With Virological Rebound Through Week 48 Time: Week 48Description: Virological rebound is defined as confirmed on-treatment HIV RNA >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA >=50 c/m, latter analysis performed on subjects with baseline HIV RNA < 50 c/mL.
Measure: Percentage of Participants With Virological Rebound Through Week 96 Time: Week 96Description: This Kaplan-Meier life table reports the cumulative proportion of participants without treatment failure up to the end of the respective time interval. Failure time is measured from the start of study therapy, and is based on the earliest event defining failure (virologic rebound at or before Week 96, or discontinuation prior to Week 96).
Measure: Cumulative Proportion of Participants Without Treatment Failure Through Week 100 Time: Through Week 100Description: Virologic rebound is defined as confirmed on-study HIV RNA ≥ 400 c/mL or last on-study HIV RNA ≥ 400 c/mL followed by treatment discontinuation.
Measure: Proportion of Participants With Virologic Rebound Through Week 96 Time: Through Week 96Measure: Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 Time: Baseline, Week 24
Measure: Mean Change From Baseline in CD4 Cell Count at Week 48 Time: Baseline, Week 48
Measure: Mean Change From Baseline in CD4 Cell Count at Week 96 Time: Baseline, Week 96
Description: AE=any new untoward medical occurrence or worsening of a pre-existing medical condition that does not necessarily have a causal relationship to treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. AE grades are: mild (1), moderate (2), severe (3), life-threatening (4), and death (5).
Measure: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs Time: From Baseline through Week 96Description: Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.
Measure: Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48 Time: Baseline, Week 48Description: Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.
Measure: Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96 Time: Baseline, Week 96Description: International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.
Measure: Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48 Time: Week 48Description: International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.
Measure: Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96 Time: Week 964 Prospective Clinical Trial to Assess Safety and Efficacy of DRV/r(TMC 114/r), ETV(TMC 125) and MK-0518 in Addition to OBT in HIV-1 Infected Patients With Limited to No Treatment Options ANRS 139 TRIO
The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant viruses and limited treatment options. An optimized background regimen that may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added, if possible, to this combination. Patients will undergo treatment for 48 weeks and virological efficacy will be evaluated at week 24.
NCT00460382 HIV Infections Drug: raltegravir potassium Drug: darunavir/ritonavir Drug: etravirine Drug: Optimized background regimen MeSH:HIV Infections
- Genotypic resistance testing at the screening visit: - Protease inhibitor mutations: over or equal to 3 primary protease inhibitor mutations among: D30N, V32I, L33F, M46I/L, I47A/V, G48V, I50L/V, I54M, L76V, V82A/F/L/T/S, I84V, N88S and L90M (IAS list 2006) but below or equal to 3 mutations among the following: V11I, V32I, L33F, I47V, I50V, I54L/M, G73S, L76V, I84V et L89V (virus sensitivity to darunavir/ritonavir). - Reverse transcriptase mutations: over or equal to 3 NRTI mutations (among IAS list) and below or equal to 3 mutations among: A98G, L100I, K101Q/P/E, K103H/N/S/T, V106A/M, V108I, E138G/K/Q, V179D/E/F/G/I, Y181C/I/V/C/H/L, Y188C/H/L, G190A/C/E/Q/S, P225H, F227C/L, M230I/L, P236L, K238N/T and Y318F (virus sensitivity to etravirine) Exclusion Criteria: - Non effective barrier contraception in women of child bearing potential - Pregnant women or women who are breastfeeding - Opportunistic infection at the acute phase - Decompensated cirrhosis (stage B or C of Child-Pugh score) - Malignancy requiring chemotherapy or radiotherapy - Contraindicated medications being taken by the patient (listed in protocol) - Allergy to the active substances and expedients of darunavir, etravirine and raltegravir. --- D30N --- --- V32I --- --- L33F --- --- M46I --- --- I47A --- --- G48V --- --- I50L ---
Primary Outcomes
Measure: Proportion of patients with HIV RNA levels of less than 50 copies/ml in an intent to treat analysis at week 24 Time: week 24Secondary Outcomes
Measure: Proportions of patients with HIV RNA levels of less than 50 copies/ml at week 48, with HIV RNA levels of less than 400 copies/ml at weeks 24 and 48 Time: week 24 and 48Measure: HIV RNA level evolution between baseline and week 48 Time: from week 0 to 48
Measure: HIV proviral DNA and 2LTR circle HIV DNA between baseline and week 48 Time: from week 0 to 48
Measure: Number and type of resistance mutations in case of virologic failure occurrence Time: from week 0 to 48
Measure: CD4 lymphocyte count and proportion evolution between baseline and week 48 Time: from week 0 to 48
Measure: HIV infection progression Time: from week 0 to 48
Measure: Frequency of the study regimen modifications and interruption Time: from week 0 to 48
Measure: Study regimen tolerance Time: from week 0 to 48
Measure: Study regimen adherence Time: from week 0 to 48
Measure: Association between study drugs' minimum concentrations at week 4 and week 12 and virologic success at week 24 Time: from week 4 to 24
Measure: Evolution of pharmacokinetics parameters of study drugs in the PK substudy Time: betwwen week 1 and 4
5 Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/Ritonavir (ATV/r) in Adolescents With CD4 + T Cells > 350 Cells/mm3 Initiating HAART
This study proposes to evaluate a pre-DHHS guideline of HAART initiation and then de-intensification management strategy in adolescents with mild immunosuppression and compare changes in CD4% from baseline to week 48 and then during de-intensification.
NCT00491556 HIV Infections Procedure: Early Initiation of Highly Active Anti-Retroviral Therapy Procedure: Standard Care MeSH:HIV Infections
The following genotypic mutations exclude subjects from participation in ATN 061: Major ATV mutations I50L; I84V; N88D/S, Major PI mutations including: D30N; V32I; L33I/F/V; M46I/L; I47V/A; G48V; I50V/L; I54V/L/A/M/T/S; L76V; V82A/F/T/S/L; L90M, Any major PI mutation as defined by the most current IAS-USA Drug Resistance Mutations Figures that would adversely affect a subject's future PI choices, Major RT mutations: Q151M and 69 insertion complex; Decisions regarding the selection of an NRTI backbone for subjects with NRTI resistance mutations other than those described above will be made by the site PI in consultation with the protocol chair or his designee. --- I50L ---
Primary Outcomes
Measure: Difference in CD4+ T Cell Percentage Between Week 0 and Week 48 Time: Week 0 and Week 48Measure: Difference in CD4+ T Cell Percentage Between Week 48 and Week 152 Time: 152 Weeks
Secondary Outcomes
Measure: Difference in CD4+ T Cell Count Between Week 0 and Week 48 Time: 48 weeksMeasure: Difference in CD4+ T Cell Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD4+ Naïve T Cell Count Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD4+ Naïve T Cell Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD4+ Termed Central Memory (TCM) Count Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD4+ TCM Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD4+ Effector Memory (TEM)Ro Count Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD4+ TEMRo Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD4+ TEMRa Count Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD4+ TEMRa Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8+ Naïve T-Cell Count Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8+ Naïve T-Cell Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8+ TCM Count Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8+ TCM Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8+ TEMRo Count Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8+ TEMRo Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8+ TEMRa Count Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8+ TEMRa Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 Naïve CD28 Cell Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 Naïve CD28 Cell Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 Naïve CD38 Cell Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 Naïve CD38 Cell Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 Naïve CD57 Cell Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 Naïve CD57 Cell Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 Naïve T-Cell Percentage Expressing Human Leukocyte Antigen-D Related (HLA-DR) Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 Naïve T-Cell Percentage Expressing HLA-DR Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TCM CD28 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TCM CD28 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TCM CD38 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TCM CD38 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TCM CD57 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TCM CD57 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TCM HLA-DR Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TCM HLA-DR Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TEMRo CD28 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TEMRo CD28 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TEMRo CD38 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TEMRo CD38 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TEMRo CD57 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TEMRo CD57 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TEMRO HLADR Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TEMRo HLA-DR Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TEMRa CD28 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TEMRa CD28 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TEMRa CD38 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TEMRa CD38 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TEMRa CD57 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TEMRa CD57 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TEMRa HLA-DR Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TEMRa HLA-DR Percentage Between Week 48 and Week 152 Time: 152 weeks
6 Phase 2 Dose-escalating, P-C, D-B, Parallel Group Study in HIV Treatment-experienced Patients to Evaluate the Safety, Tolerability and Efficacy of PA103001-04 Administered as Functional Monotherapy for 14 Days *(PART B)
The purpose of this study is to evaluate antiretroviral activity of up to five different oral doses administered for two weeks of bevirimat versus placebo in HIV treatment experienced patients, who have documented genotypic resistance to at least one major mutation from the IAS-USA list (2007)of resistance mutations for NRTIs, NNRTIs, or PIs. Patients will also be monitored for side effects, and the pharmacokinetics of bevirimat will be determined.
NCT00511368 HIV Infections Drug: matching placebo Drug: Bevirimat MeSH:HIV Infections
- Have documented evidence of genotypic resistance in their medical records (at screening) or have resistance at screening by genotype to any major mutation from the IAS-USA list of resistance drug mutations, defined as: NRTI resistance: M41L, K65R, D67N, K70R, K70E, L74V, Y115F, M184V, M184V/I, L210W, T215Y/F, K219Q/E; NNRTI resistance: L100I, K103N, V106M, V106A/M, V108I, Y181C, Y181C/I, Y188L, Y188C/L/H, G190S/A, G190A, P225H; Major PI resistance: D30N, V32I, L33F, M46I/L, I47V/A, G48V, I50L, I50V, I54M/L, L76V, V82A/F/T, V82A/F/T/S, V82L/T, I84V, N88S, L90M - Be receiving an antiretroviral therapy regimen containing at least 3 drugs (regimens containing ritonavir must not exceed a total daily dose of 400 mg) which has been unchanged for at least 8 weeks prior to initial screening. --- M41L --- --- K65R --- --- D67N --- --- K70R --- --- K70E --- --- L74V --- --- Y115F --- --- M184V --- --- M184V --- --- L210W --- --- T215Y --- --- K219Q --- --- L100I --- --- K103N --- --- V106M --- --- V106A --- --- V108I --- --- Y181C --- --- Y181C --- --- Y188L --- --- Y188C --- --- G190S --- --- G190A --- --- P225H --- --- D30N --- --- V32I --- --- L33F --- --- M46I --- --- I47V --- --- G48V --- --- I50L ---
Primary Outcomes
Measure: HIV-1 RNA change from baseline over the first 14 days of study Time: 14 daysSecondary Outcomes
Measure: safety and tolerability; pharmacokinetics Time: 14 days7 A Phase II, Randomized Trial of Open-Label Truvada With Darunavir/Ritonavir Versus Multiclass Therapy With Truvada, Darunavir/Ritonavir, Maraviroc and Raltegravir in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects
The researchers are involved in a phase II, randomized, two-arm study, comparing the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced darunavir with Truvada to a 5-drug multi-class regimen including truvada, darunavir/ritonavir/maraviroc/and raltegravir on acutely HIV-1-infected, antiretroviral (ARV) drug-naïve men and women. Subjects will participate for at least 60 weeks and up to 96 weeks if in the opinion of the investigator and patient that continued therapy is in the patient's best interest. Hypotheses: - Multi-class antiretroviral therapy (ART) is superior to RTV-enhanced ATV in combination with Emtricitabine/Tenofovir DF (FTC/TDF) with respect to suppression of viral replication. - Multi-class ART is superior to RTV-enhanced ATV in combination with FTC/TDF with respect to immune reconstitution in peripheral blood and in the gastrointestinal mucosa. - Multi-class ART is equivalent to RTV-enhanced ATV in combination with FTC/TDF with respect to tolerability.
NCT00525733 HIV Infections Drug: darunavir 800 mg Drug: FTC 200 mg/TDF 300mg Drug: Maraviroc Drug: Raltegravir Drug: Ritonavir 100 mg MeSH:Infection HIV Infections
Major resistance-associated mutations include: NRTI: K65R or inserts Q151M, M184V/I, PI: I50L/V, I84V, N88S. --- K65R --- --- Q151M --- --- M184V --- --- I50L ---
Primary Outcomes
Measure: The Primary Outcome of This Study is the Proportion of Patients Having Detectable HIV-1 RNA Using the Single Copy Assay After 48 Weeks of Treatment and the Study Hypothesis is That New Treatment is Better Than the Control Group. Time: 48 weeks8 A Pilot Trial Evaluating Maintenance Therapy With Lamivudine(Epivir®) and Dolutegravir(Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple HAART - ANRS 167 Lamidol
The principal objective is to evaluate the antiviral efficacy of 48 weeks treatment with the two-drugs combination dolutegravir(Tivicay®) and lamivudine(TEpivir®) in HIV-1 infected patients virologically suppressed with triple HAART.
NCT02527096 HIV-1 Infection Drug: dolutegravir (Tivicay®) - Phase 1 Drug: lamivudine (Epivir®) - Phase 2 Drug: dolutegravir (Tivicay®) - Phase 2 MeSH:Acquired Immunodeficiency Syndrome HIV Infections
Inclusion Criteria: - HIV-1 infected patient - Age ≥ 18 years - CD4 cell count nadir > 200/mm3 - Genotype on pre-HAART interpreted with the last version of the ANRS AC11 resistance group's algorithm which presents: - no major mutation on protease among: D30N, V32I, M46I/L, I47A/V, G48V, I50L/V, 154M/L, L76V, V82A/F/T/S, I84V, N88D/S, L90M,- no mutation on RT (except the mutation A98S if the patient is not infected by the virus subtype C), - no mutation on integrase (if the genotype is available), - First-line treatment with suppressive triple HAART (2 NRTI + either 1 PI/r, 1 NNRTI or 1 INI). --- D30N --- --- V32I --- --- M46I --- --- I47A --- --- G48V --- --- I50L ---
Primary Outcomes
Description: Virological failure is defined by plasma HIV RNA > 50 cp/mL on 2 following samples at 2 to 4 weeks apart.
Measure: Virological success without any intercurrent event leading to interrupt the strategy of the trial (analysis) Time: from week 8 to week 56 (± 4 weeks)Secondary Outcomes
Description: Evaluation was calculated as the CD4 count at the corresponding week minus the baseline CD4 count
Measure: Evolution of CD4 and CD8 lymphocytes count (analysis) Time: from week 8 to week 32 and week 56Measure: Percentage of participants who discontinued the strategy of the trial for toxicity or with adverse event of grade 3 or 4 (analysis) Time: week 56
Measure: Profile of resistance mutations in plasma in case of virological failure Time: week 56
Measure: Percentage of participants with plasma HIV RNA < 1 cp/mL Time: Day 0, week 8, week 32 and week 56
Description: Influence of total DNA at Day 0 on the occurrence of virological failure or blip
Measure: Influence of total DNA on the occurrence of virological failure or blip Time: from Day 0 to week 56Measure: Measure of concentrations of dolutegravir(Tivicay®) and lamivudine(Epivir®) in case of virological failure or with a blip Time: week 56
Measure: Measure of adherence to treatment (self-reported) Time: Day 0, week 4, week 8, week 32 and week 56
Measure: Measure of quality of life (self-reported) Time: Day 0, week 8 and week 56
Description: Evaluation of medico-economic aspects. Evaluate the direct medical cost related to dolutegravir and lamivudine versus the cost of the previous treatment.
Measure: Comparison of Medico-economic substudy (analysis) Time: week 56Description: Measure of concentrations of dolutegravir and NRTI, and HIV RNA in semen at Week 8 and Week 32 in a subgroup of 20 participants
Measure: Sperm substudy measure of concentration Time: Week 8 and week 32