- Number of Participants With HIV RNA < 400 c/mL at Week 48 [ Time Frame: Baseline (Day 1) and Week 48 ] [ Designated as safety issue: No ]
HIV RNA < 400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant responded to treatment.
- Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm) [ Time Frame: Baseline (Day 1) and Week 48 ] [ Designated as safety issue: No ]
TLOVR defines responders at Week 48 as participants with confirmed HIV RNA <400 c/mL through Week 48 without intervening virologic rebound or treatment discontinuation. Virologic rebound is defined as confirmed on-treatment HIV RNA <400 c/mL or last on-treatment HIV RNA <400 c/mL followed by discontinuation. Participants are considered failures in this analysis if they experienced virologic rebound at or before Week 48, discontinued before Week 48, never responded by Week 48, never received study therapy or had missing HIV RNA at Week 48 and beyond.
- Reduction of log10 HIV RNA Levels From Baseline to Week 48 [ Time Frame: Baseline (Day 1) and Week 48 ] [ Designated as safety issue: No ]
Changes from baseline in log10 HIV RNA levels were calculated.
- Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48 [ Time Frame: Baseline (Day 1) and Week 48. ] [ Designated as safety issue: No ]
Mean change from baseline in CD4 cell counts was determined.
- Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48 [ Time Frame: Baseline (Day 1) and Week 48 ] [ Designated as safety issue: Yes ]
Participants with virologic failure are those who never suppressed (HIV RNA <400 c/mL) and were on study through Week 48, or who rebounded to HIV RNA >= 400 c/mL and those who discontinued due to insufficient viral load response. IAS=International AIDS Society, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change
- Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48 [ Time Frame: From baseline (Day 1) to Week 48. ] [ Designated as safety issue: Yes ]
AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.
- Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC) [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ] [ Designated as safety issue: Yes ]
Hematology abnormalities were graded per modified World Health Organization (WHO) criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 - 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 - 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.
- Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48 [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ] [ Designated as safety issue: Yes ]
Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: Creatine phosphokinase (CPK): Grade 3: 5.1 - 10.0 * upper limit of normal (ULN), Grade 4: >10* ULN; Lipase: Grade 3: 2.10 - 5.0* ULN, Grade 4: 5.0* ULN.
- Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48 [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ] [ Designated as safety issue: Yes ]
Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 3 and 4 criteria were: alanine aminotransferase (ALT), aspartate aminotransferase(AST), alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.
- Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48 [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, and 48. ] [ Designated as safety issue: Yes ]
Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Blood urea nitrogen (BUN): Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 - 15.0 mg/dL, Grade 4: >15.0 mg/dL.
- Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48 [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ] [ Designated as safety issue: Yes ]
Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 - 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1-6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L.
- Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48 [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ] [ Designated as safety issue: Yes ]
Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day.
- Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48 [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ] [ Designated as safety issue: Yes ]
Laboratory measurements marked as abnormal, as per National Cholesterol Education Program (NCEP)- Adult Treatment Panel (ATP)-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.
- Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48 [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ] [ Designated as safety issue: Yes ]
Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.
- Mean Change in Weight From Baseline at Week 48 [ Time Frame: Baseline (Day 1) and Week 48 ] [ Designated as safety issue: Yes ]
Mean change in body weight from baseline was determined.
- Mean Change in Body Mass Index (BMI) in Participants at Week 48 [ Time Frame: Baseline (Day 1) and Week 48 ] [ Designated as safety issue: No ]
Mean change in BMI from baseline at Week 48 was determined.
- Mean Change in Fasting Lipid at Week 48 [ Time Frame: Baseline (Day 1) and Week 48. ] [ Designated as safety issue: No ]
Mean change from baseline in fasting lipids, for fasting total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, and triglycerides at Week 48 were determined.
- Mean Change in Fasting Glucose at Week 48 [ Time Frame: Baseline (Day 1) and Week 48. ] [ Designated as safety issue: No ]
Mean change from baseline in fasting glucose at Week 48.
- Mean Change in Fasting Insulin at Week 48 [ Time Frame: Baseline (Day 1) and Week 48. ] [ Designated as safety issue: No ]
Mean change from baseline in fasting insulin at Week 48.
- Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24 [ Time Frame: Baseline (Day 1) and Week 24. ] [ Designated as safety issue: No ]
Medical Outcomes Study HIV Health Survey (MOS-HIV) is developed to assess a patient's health and functional status associated with HIV infection. The MOS-HIV questionnaire is applied to participants with adequate linguistic skills. The subscale and summary scores range from 0-100 with a higher score indicating better health.
- Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48 [ Time Frame: Baseline (Day 1) and Week 48 ] [ Designated as safety issue: No ]
MOS-HIV is developed to assess a participant's health and functional status associated with HIV infection. The questionnaire is applied to participants with adequate linguistic skills and consists of 35 items. The questionnaire derives an overall health score and 10 subscale scores (health transitions, pain, physical functioning, role functioning, social functioning, cognitive functioning, mental health, energy/fatigue, health distress and quality of life).The subscale and summary scores range from 0-100 with a higher score indicating better health.
- Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL) [ Time Frame: IBS-QoL is administered at baseline (Day 1) and Week 4. ] [ Designated as safety issue: No ]
The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.
- Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL) [ Time Frame: IBS-QoL is administered at baseline (Day 1) and Week 12. ] [ Designated as safety issue: No ]
The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.
- Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL) [ Time Frame: Baseline (Day 1) and Week 24 ] [ Designated as safety issue: No ]
The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.
- Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Adherence to regimen was defined as taking 100% of medicine (all doses and numbers of pills as prescribed for each medicine). This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.
- Number of Participants With HIV RNA < 50 c/mL) at Week 96 [ Time Frame: Baseline (Day 1) and Week 96 ] [ Designated as safety issue: No ]
HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant has responded to treatment.
- Number of Participants With HIV RNA < 400 c/mL) at Week 96 [ Time Frame: Baseline (Day 1) and Week 96 ] [ Designated as safety issue: No ]
HIV RNA <400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant has responded to treatment.
- Reduction of log10 HIV RNA Levels From Baseline at Week 96 [ Time Frame: Baseline (Day 1) and Week 96 ] [ Designated as safety issue: No ]
Changes from baseline in log10 HIV RNA levels were calculated.
- Mean Change From Baseline in CD4 Cell Count at Week 96 [ Time Frame: Baseline (Day 1) and Week 96 ] [ Designated as safety issue: No ]
Mean change from baseline in CD4 count among treated participants was determined.
- Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96 [ Time Frame: From Day 1 through Week 96 ] [ Designated as safety issue: Yes ]
AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.
- Mean Changes in Fasting Lipids at Week 96 [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ] [ Designated as safety issue: No ]
Mean change from baseline in fasting lipids at Week 96 was determined.
- Mean Changes in Fasting Glucose at Week 96 [ Time Frame: Baseline (Day 1) and Week 96 ] [ Designated as safety issue: No ]
Mean change from baseline in fasting glucose at Week 96 was determined.
- Mean Changes in Fasting Insulin at Week 96 [ Time Frame: Baseline (Day 1) and Week 96. ] [ Designated as safety issue: No ]
Mean change from baseline in fasting insulin at Week 96.
- Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96 [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ] [ Designated as safety issue: Yes ]
Hematology abnormalities were graded per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 - 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 - 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.
- Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96 [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ] [ Designated as safety issue: Yes ]
Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: CPK: Grade 3: 5.1 - 10.0 * ULN, Grade 4: >10* ULN; Lipase: Grade 3: 2.10 - 5.0* ULN, Grade 4: 5.0* ULN.
- Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96 [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ] [ Designated as safety issue: Yes ]
Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per NCI-CTCAE. Grade 3 and 4 criteria were: ALT, AST, alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.
- Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96 [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ] [ Designated as safety issue: Yes ]
Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: BUN: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 - 15.0 mg/dL, Grade 4: >15.0 mg/dL.
- Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96 [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ] [ Designated as safety issue: Yes ]
Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 - 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1-6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L.
- Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96 [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ] [ Designated as safety issue: Yes ]
Laboratory measurements marked as abnormal, as per NCEP-ATP-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.
- Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96 [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ] [ Designated as safety issue: Yes ]
Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.
- Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96 [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ] [ Designated as safety issue: Yes ]
Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day.
- Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96 [ Time Frame: Baseline (Day 1) and Week 96. ] [ Designated as safety issue: No ]
Virologic failure participants defined as participants who were never suppressed (HIV RNA < 400 c/mL) and on study through Week 48, or who rebounded to HIV RNA ≥ 400 c/mL, and those who discontinued due to insufficient viral load response using CVR (NC=F). IAS-USA=International AIDS Society-United States of America, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184/V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change
- Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48 [ Time Frame: DEXA scans were taken at Baseline (Day 1) and at Weeks 48. ] [ Designated as safety issue: No ]
Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement was associated with a decrease in values.
- Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48 [ Time Frame: DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48. ] [ Designated as safety issue: No ]
The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: a physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.
- Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96 [ Time Frame: Baseline (Day 1) and Week 96. ] [ Designated as safety issue: No ]
The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.
- Median Changes From Baseline at Week 96 in VAT-to-TAT, VAT-to-SAT and, Trunk-to-limb Fat Ratio Measured by Computed Tomography (CT)/DEXA [ Time Frame: Baseline (Day 1) and Week 96. ] [ Designated as safety issue: No ]
- Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48 [ Time Frame: DEXA scans were taken at Baseline (Day 1) and Week 48. ] [ Designated as safety issue: No ]
Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.
- Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96 [ Time Frame: Baseline (Day 1) and Week 96 ] [ Designated as safety issue: No ]
Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.
- Mean Change From Baseline in Body Weight at Week 96 [ Time Frame: Baseline (Day 1) and Week 96 ] [ Designated as safety issue: No ]
Mean change from baseline in weight at Week 96
- Mean Change From Baseline in Body Weight at Week 48 [ Time Frame: Baseline (Day 1) and Week 48 ] [ Designated as safety issue: No ]
Mean change from baseline in body weight at Week 48 was determined.
- Mean Change From Baseline in BMI at Week 96 [ Time Frame: Baseline (Day 1) and Week 96 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Waist Circumference at Week 96 [ Time Frame: Baseline (Day 1) and Week 96. ] [ Designated as safety issue: No ]
Mean change From baseline in waist circumference at Week 96 was determined.
- Mean Change From Baseline in Waist Circumference at Week 48 [ Time Frame: Baseline (Day 1) and Week 48 ] [ Designated as safety issue: No ]
Mean change from baseline in waist circumference at Week 48 was determined.
- Mean Change From Baseline in Waist-to-hip-ratio at Week 96 [ Time Frame: Baseline (Day 1) and Week 96 ] [ Designated as safety issue: No ]
Mean change from baseline in waist-to-hip-ratio at Week 96 was determined.
- Mean Change From Baseline in BMI at Week 48 [ Time Frame: Baseline (Day 1) and Week 48. ] [ Designated as safety issue: No ]
Mean change from baseline in BMI at Week 48 was determined.
- Mean Change From Baseline in Waist-to-hip-ratio at Week 48 [ Time Frame: Baseline (Day 1) and Week 48 ] [ Designated as safety issue: No ]
Mean change from baseline in waist-to-hip-ratio at Week 48 was determined.
- Percentage of Participants With Lipoatrophy at Week 96 [ Time Frame: Baseline (Day 1) and Week 96 ] [ Designated as safety issue: No ]
Lipoatrophy, redistribution of body fat was defined as >= 20% decrease in limb fat. The percentage of participants with lipoatrophy from baseline was determined.
- Mean Changes From Baseline in Body Weight at Week 96 [ Time Frame: Physical examination was performed at Baseline (Day 1) and Weeks 48 and 96. ] [ Designated as safety issue: No ]
Mean change in body weight from baseline was determined.
- Mean Change From Baseline in BMI at Week 96 [ Time Frame: Baseline (Day 1) and Week 96 ] [ Designated as safety issue: No ]
Mean change From baseline in BMI at Week 96 was determined.