Primary Outcomes

Description: Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA >= 1000 copies/ml or confirmed rebound from the week 4 value by >0.5 log10 copies/ml (for subjects with week 4 value <= 50 copies/ml, confirmed rebound to >50 copies/ml); at week 24 or later, confirmed value > 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.

Measure: Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24

Time: From start of study treatment to week 24

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Secondary Outcomes

Description: The proportion of participants with virologic failure (see primary outcome measure for definition) and/or premature treatment discontinuation/modification and/or death was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.

Measure: Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24

Time: From start of study treatment to Week 24

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Description: Results report the week 1 change from baseline (week 1 - baseline) in HIV-1 RNA. Baseline HIV-1 RNA was computed as the mean of the log10 HIV-1 RNA values at pre-entry and study entry.

Measure: Change in Plasma HIV-1 RNA From Baseline to Week 1

Time: Baseline and week 1

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Description: Results report the percentage of participants with plasma HIV-1 RNA < 50 copies/ml or <200 copies/ml at week 24.

Measure: Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24

Time: From start of study treatment to week 24

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Description: Results report the percentage of participants with plasma HIV-1 RNA <50 copies/ml or <200 copies/ml at week 48.

Measure: Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48

Time: From start of study treatment to week 48

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Description: Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Results report the percentage of participants who had grade 3 or higher events, or events of any grade which led to a permanent change or discontinuation of study treatment, which occurred any time from start of treatment to end of treatment.

Measure: Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment

Time: From start of study treatment to week 52

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Description: Results report the number of participants who had resistance to non-nucleoside reverse transciptase inhibitors (NNRTI), nucleoside reverse transciptase inhibitors (NRTI) and protease inbitors (PI) based on genotypic resistance testing done prior to participant's entry into the study. Participants are classified into one (and only one category) based on the maximum number of drug class resistance seen for the participant.

Measure: Number of Participants With Pretreatment Drug Resistance

Time: At screening

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Description: Results report the number of participants who had integrase resistance mutation(s) detected at the time of virologic failure.

Measure: Number of Participants With Integrase Drug Resistance at Virologic Failure

Time: From 12 weeks after starting study treatment to week 52

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Description: Results report the number of participants who had protease resistance mutation(s) detected at the time of virologic failure.

Measure: Number of Participants With Protease Drug Resistance at Virologic Failure

Time: From 12 weeks after starting study treatment to week 52

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Description: At each study visit, adherence was measured in terms of the number of missed doses each participant had over a 4-day recall for each drug. Adherence for all study visit weeks were combined for an overall measure of adherence. Participants who had zero missed doses on all weeks in all drugs while on study were classified as having an overall "perfect" adherence.

Measure: Number of Participants With Perfect Overall Adherence by Self Report

Time: From one week after starting study treatment to week 52

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Description: Results report the week 24 change from week 0 (week 24 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.

Measure: Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24

Time: From start of study treatment through week 24

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Description: Results report the week 24 change from week 0 (week 24 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.

Measure: Change in Fasting Low-density Lipoprotein at Week 24

Time: From start of study treatment through week 24

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Description: Results report the week 48 change from week 0 (week 48 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.

Measure: Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48

Time: From start of study treatment through week 48

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Description: Results report the week 48 change from week 0 (week 48 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.

Measure: Change in Fasting Low-density Lipoprotein at Week 48

Time: From start of study treatment through week 48

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Description: Results report the week 48 change from baseline (week 48 - baseline) in CD4 count. Baseline CD4 count was computed as the mean of CD4 count values at pre-entry and study entry.

Measure: Change in CD4 Count at Week 48

Time: From start of study treatment through week 48

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Description: Plasma trough concentrations (ng/ml) of Raltegravir (RAL) below the detection limit (10 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 9-15 hours after the last RAL dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.

Measure: Plasma Trough Concentration of Raltegravir

Time: From start of study treatment to week 52

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Description: Plasma trough concentrations (ng/ml) of Darunavir (DRV) below the detection limit (50 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 20-28 hours after the last DRV dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.

Measure: Plasma Trough Concentration of Darunavir

Time: From start of study treatment to week 52

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Primary Outcomes

Description: Compare between arms the proportion of patients maintaining virologic suppression (i.e., no confirmed HIV RNA levels ≥200 copies/mL) at Week 24

Measure: Virologic suppression (24 weeks)

Time: 24 weeks

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Secondary Outcomes

Description: Evaluate the proportion of participants who maintain virologic suppression 24 weeks post-switch (i.e. at 24 weeks in the immediate switch arm and at 48 weeks in the delayed switch arm)

Measure: Virologic Suppression (48 weeks)

Time: 48 weeks

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Primary Outcomes

Measure: DTG PK Parameter Maximum Plasma Concentration (Cmax) by visit week and arm

Time: Measured at Days 0 and 28

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Measure: DTG PK Parameter Area Under the Curve (AUC0-12 for BID & AUC0-24 for QD dosing) by visit week and arm

Time: Measured at Days 0 and 28

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Measure: DTG PK Parameter Minimum Plasma Concentration (Cmin) by visit week and arm

Time: Measured at Days 0 and 28

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Secondary Outcomes

Description: Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017

Measure: Proportion of participants with all adverse events meeting the reporting criteria in the study protocol during administration of DTG with 1HP, by arm

Time: Measured through Week 4

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Measure: Proportion of participants who discontinue study or study drugs during DTG and 1HP dosing, by arm

Time: Measured through Week 4

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Measure: Proportion of participants with HIV-1 RNA levels >50 copies/mL

Time: Measured at Days 28 and 42

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