Active, not recruiting

Study Description:

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)

Viiv Study ID:

117172


Has Results Document Available
Clinicaltrials.gov Identifier:

NCT01910402


Has Results Available Below
EudraCT Number:

2012-005823-34


Study Overview

Medical Conditions

Human Immunodeficiency Virus (HIV)

Product

GSK2326285;abacavir;abacavir/lamivudine;atazanavir;dolutegravir;dolutegravir/abacavir/lamivudine;lamivudine;ritonavir

Collaborators

GlaxoSmithKline


Date

August 2013 to December 2020

Type

Interventional

Phase

3


Gender

Female

Age

18 years - N/A

Accepts Healthy Volunteers

No


Study Documents

This study has Protocol and Result summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    US GSK Clinical Trials Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]

Argentina, Buenos Aires, Buenos Aires 1141Recruiting
Argentina, Buenos Aires, Ciudad Autónoma de Buenos Aires C1405CKCRecruiting
Argentina, Buenos Aires, Ciudad de Buenos Aires C1202ABBRecruiting
Canada, British Columbia, Vancouver V6Z 1Y6Completed
Canada, Ontario, Ottawa K1H 8L6Completed
Canada, Ontario, Toronto M5G 2N2Completed
Canada, Ontario, Toronto M4N 3M5Completed
Canada, Québec, Montreal H2X 2P4Completed
France, Bobigny 93009Completed
France, Nantes 44093Completed
France, Paris Cedex 10 75475Completed
Italy, Liguria, Genova 16128Completed
Italy, Lombardia, Bergamo 24127Completed
Italy, Lombardia, Brescia 25123Completed
Italy, Lombardia, Busto Arsizio (VA) 21052Completed
Italy, Lombardia, Milano 20127Completed
Italy, Lombardia, Milano 20157Completed
Italy, Piemonte, Torino 10149Completed
Mexico, Mexico 14000Completed
Mexico, Jalisco, Guadalajara 44280Recruiting
Portugal, Amadora 2720-276Recruiting
Portugal, Lisboa 1150Recruiting
Portugal, Porto 4200-319Recruiting
Puerto Rico, Puerto Rico, Ponce 00717Completed
Puerto Rico, Puerto Rico, Rio Piedras 00936Terminated
Puerto Rico, Puerto Rico, San Juan 00909Completed
Russia, Moscow 105275Recruiting
Russia, Orel 302040Recruiting
Russia, Smolensk 214006Recruiting
Russia, St. Petersburg 196645Recruiting
Russia, St. Petersburg 190103Recruiting
Russia, Toliyatti 445846Recruiting
South Africa, Mamelodi East Recruiting
South Africa, Western Province, Observatory 7925Recruiting
Spain, (Móstoles) Madrid 28935Completed
Spain, Alicante 03010Completed
Spain, Badalona 08916Completed
Spain, Barcelona 08907Completed
Spain, Barcelona 08035Completed
Spain, Granada 18012Completed
Spain, Madrid 28046Completed
Spain, Madrid 28034Completed
Spain, Malaga 29010Completed
Spain, Murcia 30003Completed
Spain, Sevilla 41013Completed
Thailand, Bangkok 10330Recruiting
Thailand, Nonthaburi 11000Recruiting
United Kingdom, Birmingham B9 5SSCompleted
United Kingdom, London W2 1NYCompleted
United Kingdom, London E1 1BBCompleted
United Kingdom, London NW3 2QGCompleted
United Kingdom, Sheffield S10 2JFCompleted
United Kingdom, Tooting, London SW17 0QTCompleted
United States, Arizona, Phoenix 85015Completed
United States, California, Bakersfield 93301Completed
United States, California, Beverly Hills 90211Completed
United States, California, Los Angeles 90033Terminated
United States, California, Los Angeles 90035Terminated
United States, District of Columbia, Washington 20007Completed
United States, Florida, Fort Pierce 34982Completed
United States, Florida, Miami 33133Completed
United States, Florida, Miami 33136Terminated
United States, Florida, Orlando 32803Completed
United States, Florida, Tampa 33602Completed
United States, Florida, Tampa 33614Terminated
United States, Florida, West Palm Beach 33401Completed
United States, Georgia, Atlanta 30309Completed
United States, Georgia, Augusta 30912-3130Completed
United States, Georgia, Decatur 30033Completed
United States, Georgia, SAVANNAH 31401Completed
United States, Indiana, Indianapolis 46202Completed
United States, Iowa, Iowa City 52242Terminated
United States, Maryland, Baltimore 21201Terminated
United States, Massachusetts, Springfield 01199Completed
United States, Michigan, Detroit 48202Completed
United States, Missouri, Kansas City 64111Completed
United States, Missouri, St. Louis 63110Completed
United States, Nebraska, Omaha 68198Completed
United States, Nevada, Las Vegas 89106Completed
United States, New Jersey, Neptune 7754Completed
United States, New Jersey, Newark 07103Completed
United States, New Jersey, Newark Terminated
United States, New York, Buffalo 14215Completed
United States, New York, Valhalla 10595Completed
United States, North Carolina, Chapel Hill 27514Completed
United States, North Carolina, Charlotte 28207Completed
United States, North Carolina, Gastonia 28054Terminated
United States, North Carolina, Greensboro 27401-1209Completed
United States, North Carolina, Winston-Salem 27157-1042Terminated
United States, Oklahoma, Oklahoma City 73103Terminated
United States, Pennsylvania, Allentown 18102Completed
United States, Pennsylvania, Philadelphia 19107Completed
United States, Pennsylvania, Philadelphia 19104Completed
United States, Pennsylvania, Philadelphia 19140Completed
United States, Texas, Bellaire 77401Completed
United States, Texas, Dallas 75246Completed
United States, Texas, Dallas 75235Completed
United States, Texas, El Paso 79905Completed
United States, Texas, Fort Worth 76104Completed
United States, Utah, Salt Lake City 84132Terminated
United States, Virginia, Lynchburg 24501Completed

Study Design

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48
    Timeframe: Week 48

Secondary Outcomes:

  • Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL over time
    Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

  • Change from Baseline in Plasma HIV-1 RNA at indicated time points
    Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

  • Change from Baseline in CD4+ cell count at indicated timepoints
    Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

  • Change from Baseline in carbon dioxide, electrolytes, lipids, glucose, urea at indicated time points
    Timeframe: Baseline, Week 4, 12, 24, 36, 48

  • Change from Baseline in bilirubin and creatinine at indicated timepoints.
    Timeframe: Baseline, Week 4, 12, 24, 36, 48

  • Change from Baseline in albumin at indicated timepoints.
    Timeframe: Baseline, Week 4, 12, 24, 36, 48

  • Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase at indicated time points
    Timeframe: Baseline, Week 4, 12, 24, 36, 48

  • Change from Baseline in creatinine clearance at indicated time points
    Timeframe: Baseline, Week 4, 12, 24, 36, 48

  • Change from Baseline in lipase at indicated timepoints.
    Timeframe: Baseline, Week 4, 12, 24, 36, 48

  • Change from Baseline in total CHLS/HDL CHLS ratio at indicated timepoints.
    Timeframe: Baseline, Week 4, 12, 24, 36, 48

  • Change from Baseline in basophils, eosinophils, lymphocytes, monocytes at indicated time points
    Timeframe: Baseline, Week 4, 12, 24, 36, 48

  • Change from Baseline in erythrocytes at indicated time points.
    Timeframe: Baseline, Week 4, 12, 24, 36, 48

  • Change from Baseline in hematocrit count at indicated time points.
    Timeframe: Baseline, Week 4, 12, 24, 36, 48

  • Change from Baseline in erythrocyte mean corpuscular volume at indicated time points.
    Timeframe: Baseline, Week 4, 12, 24, 36, 48

  • Change from Baseline in Triglycerides at Week 48
    Timeframe: Baseline and Week 48

  • Change from Baseline in TC/HDL Ratio at Week 48
    Timeframe: Baseline and Week 48

  • Change from Baseline in urine albumin creatinine ratio at indicated time points
    Timeframe: Baseline, Week 24, Week 48

  • Summary of AEs by maximum toxicity as per DAIDS AE Grading Table.
    Timeframe: Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC

  • Number of participants with any adverse events (AEs), and serious adverse events (SAEs)
    Timeframe: 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)

  • Summary of maximum post-Baseline emergent chemistry toxicities
    Timeframe: Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC

  • Summary of maximum post-Baseline emergent hematology toxicities
    Timeframe: Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC

  • Number of participants who withdrew from treatment due to AEs
    Timeframe: average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC

  • Change from Baseline in bone specific alkaline phosphatase, osteocalcin and procollagen 1 N-terminal propeptide at indicated timepoints
    Timeframe: Baseline, Week 24, 48

  • Change from Baseline in Type I collagen C-telopeptides at indicated timepoints
    Timeframe: Baseline, Week 24, 48

  • Change from Baseline in vitamin D, vitamin D2 and vitamin D3 at Week 24 and Week 48
    Timeframe: Baseline, Weeks 24, 48

  • Bone specific alkaline phosphatase, osteocalcin, procollagen 1 N-terminal propeptide, Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline
    Timeframe: Baseline, Weeks 24, 48

  • Change from Baseline at Week 48 in SF-12 Total Score, MCS and PCS
    Timeframe: Baseline and Week 48

  • Assessment of HIVTSQs Total Score at indicated timepoints.
    Timeframe: Week 4, 12, 24, 48

  • Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups
    Timeframe: Week 48

  • Number of participants with post-Baseline HIV-1 disease progression
    Timeframe: Up to week 48

  • Number of Participants with treatment emergent resistances
    Timeframe: Up to week 48

Arms:
  • 2

Interventions:

  • Drug: Dolutegravir/abacavir/lamivudine FDC
  • Drug: Atazanavir
  • Drug: Ritonavir
  • Drug: Tenofovir/emtricitabine FDC

Keyword:

  • antiretroviral therapy naïve, women, once daily, HIV infection, atazanavir, tenofovir/emtricitabine, dolutegravir/abacavir/lamivudine fixed dose combination, integrase inhibitor, ritonavir
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 499