Primary Outcomes

Description: Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure.

Measure: Time From Randomization to Virologic Failure

Time: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

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Description: Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.

Measure: Time From Treatment Dispensation to a Grade 3/4 Safety Event

Time: All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.

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Description: Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Time From Treatment Dispensation to Treatment Modification

Time: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

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Secondary Outcomes

Description: Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)

Time: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

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Measure: The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL

Time: At Weeks 48 and 96

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Measure: Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL

Time: At Weeks 48 and 96

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Description: Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values).

Measure: Change in CD4 Count (Cells/mm3) From Baseline

Time: At Weeks 48 and 96

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Description: Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease.

Measure: Number of Participants With Virologic Failure and Emergence of Major Resistance

Time: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

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Description: AIDS-defining illnesses were defined per CDC category C definition. HIV-1 related events were defined per CDC category B definition. Events underwent study chair review for classification. See link below for more details. http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm

Measure: Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.

Time: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

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Description: Only fasting results are included. The protocol did not require that samples be collected fasting.

Measure: Change in Fasting Total Cholesterol Level From Baseline

Time: At Weeks 48 and 96

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Description: Only fasting results are included. The protocol did not require that samples be collected fasting.

Measure: Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline

Time: At Weeks 48 and 96

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Description: Only fasting results are included. The protocol did not require that samples be collected fasting.

Measure: Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline

Time: At Weeks 48 and 96

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Description: Only fasting results are included. The protocol did not require that samples be collected fasting.

Measure: Change in Fasting Triglyceride Level From Baseline

Time: At Weeks 48 and 96

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Other Outcomes

Description: Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact.

Measure: Amount of Study Follow-up

Time: Follow-up time was variable, median follow-up was 138 weeks

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Description: Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.

Measure: Number of Participants With Virologic Failure

Time: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

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Description: Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.

Measure: Cumulative Probability of Not Experiencing Virologic Failure

Time: At week 48 and 96

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Description: Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.

Measure: Number of Participants With a Grade 3/4 Safety Event

Time: Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks

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Description: Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.

Measure: Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event

Time: At week 48 and 96

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Description: Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Number of Participants With Treatment Modification

Time: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

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Description: Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Cumulative Probability of Not Experiencing Treatment Modification

Time: At week 48 and 96

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Description: Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Number of Participants With Regimen Failure

Time: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

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Description: Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Cumulative Probability of Not Experiencing Regimen Failure

Time: At week 48 and 96

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Primary Outcomes

Measure: Difference in CD4+ T Cell Percentage Between Week 0 and Week 48

Time: Week 0 and Week 48

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Measure: Difference in CD4+ T Cell Percentage Between Week 48 and Week 152

Time: 152 Weeks

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Secondary Outcomes

Measure: Difference in CD4+ T Cell Count Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD4+ T Cell Count Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD4+ Naïve T Cell Count Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD4+ Naïve T Cell Count Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD4+ Termed Central Memory (TCM) Count Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD4+ TCM Count Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD4+ Effector Memory (TEM)Ro Count Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD4+ TEMRo Count Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD4+ TEMRa Count Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD4+ TEMRa Count Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8+ Naïve T-Cell Count Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8+ Naïve T-Cell Count Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8+ TCM Count Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8+ TCM Count Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8+ TEMRo Count Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8+ TEMRo Count Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8+ TEMRa Count Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8+ TEMRa Count Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8 Naïve CD28 Cell Percentage Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8 Naïve CD28 Cell Percentage Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8 Naïve CD38 Cell Percentage Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8 Naïve CD38 Cell Percentage Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8 Naïve CD57 Cell Percentage Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8 Naïve CD57 Cell Percentage Between Week 48 and Week 152

Time: 152 weeks

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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

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Measure: Difference in CD8 Naïve T-Cell Percentage Expressing HLA-DR Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8 TCM CD28 Percentage Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8 TCM CD28 Percentage Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8 TCM CD38 Percentage Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8 TCM CD38 Percentage Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8 TCM CD57 Percentage Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8 TCM CD57 Percentage Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8 TCM HLA-DR Percentage Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8 TCM HLA-DR Percentage Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8 TEMRo CD28 Percentage Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8 TEMRo CD28 Percentage Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8 TEMRo CD38 Percentage Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8 TEMRo CD38 Percentage Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8 TEMRo CD57 Percentage Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8 TEMRo CD57 Percentage Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8 TEMRO HLADR Percentage Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8 TEMRo HLA-DR Percentage Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8 TEMRa CD28 Percentage Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8 TEMRa CD28 Percentage Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8 TEMRa CD38 Percentage Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8 TEMRa CD38 Percentage Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8 TEMRa CD57 Percentage Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8 TEMRa CD57 Percentage Between Week 48 and Week 152

Time: 152 weeks

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Measure: Difference in CD8 TEMRa HLA-DR Percentage Between Week 0 and Week 48

Time: 48 weeks

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Measure: Difference in CD8 TEMRa HLA-DR Percentage Between Week 48 and Week 152

Time: 152 weeks

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Primary Outcomes

Measure: Proportion of subjects with Human immunodeficiency virus 1 (HIV-1) Ribonucleic Acid (RNA) < 50 c/mL

Time: At Week 48

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Secondary Outcomes

Measure: Proportion of subjects with HIV-1 RNA < 50 c/mL

Time: At week 24

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Measure: Change from baseline in CD4 cell count

Time: Baseline (Week 0) and at week 48

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Measure: Incidence rates of serious adverse event (SAEs) and adverse events (AEs) leading to discontinuation

Time: up to week 48

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Measure: Incidence rates of antiretroviral resistance measured by newly emergent genotypic substitutions and phenotypic resistance to study drugs for virologic failure

Time: up to week 48

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Measure: Proportion of subjects with HIV-1 RNA < 50 c/mL at Week 48 by baseline M184V presence or absence

Time: Week 48

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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)

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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 56

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Measure: 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

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Measure: Profile of resistance mutations in plasma in case of virological failure

Time: week 56

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Measure: Percentage of participants with plasma HIV RNA < 1 cp/mL

Time: Day 0, week 8, week 32 and week 56

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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 56

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Measure: Measure of concentrations of dolutegravir(Tivicay®) and lamivudine(Epivir®) in case of virological failure or with a blip

Time: week 56

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Measure: Measure of adherence to treatment (self-reported)

Time: Day 0, week 4, week 8, week 32 and week 56

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Measure: Measure of quality of life (self-reported)

Time: Day 0, week 8 and week 56

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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 56

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Description: 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

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