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A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01910402
First received: July 25, 2013
Last updated: September 13, 2016
Last verified: July 2016
  Purpose
This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in HIV-1 infected, ART-naïve women over 48 weeks. This study will also characterize the safety and tolerability of DTG/ABC/3TC FDC compared to ATV+RTV+TDF/FTC FDC. Sufficient number of subjects will be screened in order to ensure a total of approximately 474 subjects will be randomized (237 in each study arm)

Condition Intervention Phase
Infection, Human Immunodeficiency Virus
Drug: Dolutegravir/abacavir/lamivudine FDC
Drug: Atazanavir
Drug: Ritonavir
Drug: Tenofovir/emtricitabine FDC
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine Once Daily Compared to Atazanavir and Ritonavir Plus Tenofovir/Emtricitabine Once Daily in HIV-1 Infected Antiretroviral Therapy Naïve Women

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells per millimetre cube (cells/mm^3) or >350 cells/mm^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomised participants who received at least one dose of study medication.


Secondary Outcome Measures:
  • Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time [ Time Frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 ] [ Designated as safety issue: No ]
    Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL were assessed at Baseline, Week 4, 12, 24 , 36 and Week 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value.

  • Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points [ Time Frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 ] [ Designated as safety issue: No ]
    Change from the Baseline in plasma HIV-1 RNA were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

  • Change From Baseline in CD4+ Cell Count at Indicated Timepoints [ Time Frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 ] [ Designated as safety issue: No ]
    Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

  • Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ] [ Designated as safety issue: No ]
    Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

  • Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints. [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ] [ Designated as safety issue: No ]
    Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

  • Change From Baseline in Albumin at Indicated Timepoints. [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ] [ Designated as safety issue: No ]
    Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

  • Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ] [ Designated as safety issue: No ]
    Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

  • Change From Baseline in Creatinine Clearance at Indicated Time Points [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ] [ Designated as safety issue: No ]
    Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

  • Change From Baseline in Lipase at Indicated Timepoints. [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ] [ Designated as safety issue: No ]
    Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

  • Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints. [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ] [ Designated as safety issue: No ]
    Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

  • Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ] [ Designated as safety issue: No ]
    Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

  • Change From Baseline in Erythrocytes at Indicated Time Points. [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ] [ Designated as safety issue: No ]
    Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

  • Change From Baseline in Hematocrit Count at Indicated Time Points. [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ] [ Designated as safety issue: No ]
    Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

  • Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points. [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ] [ Designated as safety issue: No ]
    Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

  • Change From Baseline in Triglycerides at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.

  • Change From Baseline in TC/HDL Ratio at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.

  • Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points [ Time Frame: Baseline, Week 24, Week 48 ] [ Designated as safety issue: No ]
    Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed.

  • Summary of AEs by Maximum Toxicity as Per DAIDS AE Grading Table. [ Time Frame: Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC ] [ Designated as safety issue: No ]
    Number of participants with Grade 1-4 AEs were assessed from the start of study treatment and until end of the Randimization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.

  • Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs) [ Time Frame: From start of IP through the Study Phase (Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC) ] [ Designated as safety issue: No ]
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.

  • Summary of Maximum Post-Baseline Emergent Chemistry Toxicities [ Time Frame: Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC ] [ Designated as safety issue: No ]
    Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and until the follow up contact. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.

  • Summary of Maximum Post-Baseline Emergent Hematology Toxicities [ Time Frame: Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC ] [ Designated as safety issue: No ]
    Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and until the follow up contact. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.

  • Number of Participants Who Withdrew From Treatment Due to AEs [ Time Frame: average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC ] [ Designated as safety issue: No ]
    An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.

  • Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints [ Time Frame: Baseline, Week 24, 48 ] [ Designated as safety issue: No ]
    Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.

  • Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints [ Time Frame: Baseline, Week 24, 48 ] [ Designated as safety issue: No ]
    Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.

  • Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 [ Time Frame: Baseline, Weeks 24, 48 ] [ Designated as safety issue: No ]
    Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D and vitamin D2 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.

  • Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline [ Time Frame: Baseline, Weeks 24, 48 ] [ Designated as safety issue: No ]
    Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analysed based on log transformed data. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed. Estimates of adjusted mean and difference were calculated from an ANCOVA model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC.

  • Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    The SF-12 is the 12 item abbreviated form of SF-36 survey. It provides information about how participants feel, and how well they have been able to perform their usual activities. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.

  • Assessment of HIVTSQs Total Score at Indicated Timepoints. [ Time Frame: Week 4, 12, 24, 48 ] [ Designated as safety issue: No ]
    The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.

  • Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA (BPHR), Baseline CD4+ cell count (BCCC), Baseline Centers for Disease Control and Prevention (CDC) category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.

  • Number of Participants With Post-Baseline HIV-1 Disease Progression [ Time Frame: Up to week 48 ] [ Designated as safety issue: No ]
    Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.

  • Number of Participants With Treatment Emergent Resistances [ Time Frame: Up to week 48 ] [ Designated as safety issue: No ]
    Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to INI, NNRTI, NRTI, PI will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITT-E population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.


Enrollment: 499
Study Start Date: August 2013
Estimated Study Completion Date: December 2020
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DTG/ABC/3TC FDC
As per the randomization schedule subjects will be administered with DTG/ABC/3TC (50mg/600mg/300mg) FDC tablet OD up to Week 48 and if continued if applicable in the Continuation Phase. DTG/ABC/3TC FDC may be administered with or without food
Drug: Dolutegravir/abacavir/lamivudine FDC
Dolutegravir/abacavir/lamivudine FDC tablets, 50 mg/600 mg/300 mg
Active Comparator: ATV +RTV +TDF/FTC FDC
As per the randomization schedule subjects will be administered with ATV (300mg capsule) +RTV (100mg tablet) + TDF/FTC (300mg/200mg tablet) FDC OD up to Week 48. ATV+RTV+ TDF/FTC FDC must be taken with food
Drug: Atazanavir
Atazanavir capsule 300 mg
Drug: Ritonavir
Ritonavir tablet 100 mg
Drug: Tenofovir/emtricitabine FDC
Tenofovir/emtricitabine FDC tablet 300 mg/200 mg of FTC

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-1 infected females (gender at birth) >=18 years of age
  • Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol)
  • HIV-1 infection as documented by Screening plasma HIV-1 RNA >=500 c/mL.
  • Documentation that the subject is negative for the HLA-B*5701 allele.
  • Antiretroviral-naïve (<=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection).
  • Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening.

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Women who plan to become pregnant during the first 48 weeks of the study
  • Any subject who has had a medical intervention for gender reassignment
  • Any evidence of an active Centers for Disease Control and Prevention (CDC) Category C disease
  • Subjects with any degree of hepatic impairment
  • Subjects positive for hepatitis B at Screening, or anticipated need for HCV therapy during the study
  • History or presence of allergy to the study drugs or their components or drugs of their class
  • Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia
  • poses a significant suicidality risk
  • History of osteoporosis with fracture or requiring pharmacologic therapy
  • Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
  • Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses;
  • Treatment with any agent, with documented activity against HIV-1 in vitro within 28 days of first dose of investigational product (IP)
  • Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP
  • Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation in the Screening result or, if known, any historical resistance test result
  • Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities (total cholesterol, triglycerides, High Density Lipoprotein (HDL) cholesterol, Low Density Lipoprotein (LDL) cholesterol)
  • Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound
  • Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), or ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin)
  • Subject has CrCL of <50 mL/min via Cockroft-Gault method
  • Corrected QT interval (QTc (Bazett)) ≥450msec or QTc (Bazett) ≥480msec for subjects with bundle branch block.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01910402

  Show 101 Study Locations
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01910402     History of Changes
Other Study ID Numbers: 117172 
Study First Received: July 25, 2013
Results First Received: July 25, 2016
Last Updated: September 13, 2016
Health Authority: Mexico: Ministry of Health
Portugal: The National Institue of Pharmacy and Medicines (Infarmed)
Italy: Italian Medicines Agency
Argentina: Ministry of Health - A.N.M.A.T
South Africa: Medicines Control Council
Thailand: Food and Drug Administration
United States: Food and Drug Administration
Russia: Russian Ministry of Health
France: National Agency for the Safety of Medicine and Health Products
Spain: Spanish Agency for Medicines and Health Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada

Keywords provided by ViiV Healthcare:
antiretroviral therapy naïve
women
once daily
HIV infection
atazanavir
tenofovir/emtricitabine
dolutegravir/abacavir/lamivudine fixed dose combination
integrase inhibitor
ritonavir

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Ritonavir
Atazanavir Sulfate
Tenofovir
Lamivudine
Abacavir
Dolutegravir
Emtricitabine
Dideoxynucleosides
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on December 02, 2016