Brief Summary
The primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-adults.
Brief Title
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Completion Date
Completion Date Type
Actual
Conditions
HIV-1 Infection
Eligibility Criteria
Key Inclusion Criteria:
* Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening
* Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at screening
* Adequate renal function: Estimated glomerular filtration rate ≥ 50 milliliter per minute (mL/min) (≥ 0.83 milliliter per second \[mL/sec\]) according to the Cockcroft-Gault formula
* Negative screening test for human leukocyte antigen (HLA) -B x 5701 allele provided by Gilead Sciences
Key Exclusion Criteria:
* An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening (refer to study protocol)
* Decompensated cirrhosis (e.g, ascites, encephalopathy, or variceal bleeding)
* Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
* Females who are pregnant (as confirmed by positive serum pregnancy test)
* Females who are breastfeeding
* Chronic Hepatitis B Virus (HBV) infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
* Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening
* Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at screening
* Adequate renal function: Estimated glomerular filtration rate ≥ 50 milliliter per minute (mL/min) (≥ 0.83 milliliter per second \[mL/sec\]) according to the Cockcroft-Gault formula
* Negative screening test for human leukocyte antigen (HLA) -B x 5701 allele provided by Gilead Sciences
Key Exclusion Criteria:
* An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening (refer to study protocol)
* Decompensated cirrhosis (e.g, ascites, encephalopathy, or variceal bleeding)
* Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
* Females who are pregnant (as confirmed by positive serum pregnancy test)
* Females who are breastfeeding
* Chronic Hepatitis B Virus (HBV) infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion Criteria
Inclusion Criteria:
* Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening
* Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at screening
* Adequate renal function: Estimated glomerular filtration rate ≥ 50 milliliter per minute (mL/min) (≥ 0.83 milliliter per second \[mL/sec\]) according to the Cockcroft-Gault formula
* Negative screening test for human leukocyte antigen (HLA) -B x 5701 allele provided by Gilead Sciences
Inclusion/
* Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening
* Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at screening
* Adequate renal function: Estimated glomerular filtration rate ≥ 50 milliliter per minute (mL/min) (≥ 0.83 milliliter per second \[mL/sec\]) according to the Cockcroft-Gault formula
* Negative screening test for human leukocyte antigen (HLA) -B x 5701 allele provided by Gilead Sciences
Inclusion/
Gender
All
Gender Based
false
Keywords
HIV
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02607930
Org Class
Industry
Org Full Name
Gilead Sciences
Org Study Id
GS-US-380-1489
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Primary Outcomes
Outcome Description
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome Measure
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
Outcome Time Frame
Week 48
Secondary Ids
Secondary Id
2015-004024-54
Secondary Outcomes
Outcome Description
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome Time Frame
Week 96
Outcome Measure
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
Outcome Description
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome Time Frame
Week 144
Outcome Measure
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
Outcome Description
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome Time Frame
Week 48
Outcome Measure
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
Outcome Description
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome Time Frame
Week 96
Outcome Measure
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
Outcome Description
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome Time Frame
Week 144
Outcome Measure
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
Outcome Time Frame
Baseline, Week 48
Outcome Measure
Change From Baseline in log10 HIV-1 RNA at Week 48
Outcome Time Frame
Baseline, Week 96
Outcome Measure
Change From Baseline in log10 HIV-1 RNA at Week 96
Outcome Time Frame
Baseline, Week 144
Outcome Measure
Change From Baseline in log10 HIV-1 RNA at Week 144
Outcome Time Frame
Baseline, Week 48
Outcome Measure
Change From Baseline in CD4+ Cell Count at Week 48
Outcome Time Frame
Baseline, Week 96
Outcome Measure
Change From Baseline in CD4+ Cell Count at Week 96
Outcome Time Frame
Baseline, Week 144
Outcome Measure
Change From Baseline in CD4+ Cell Count at Week 144
Outcome Time Frame
Baseline, Week 48
Outcome Measure
Percentage Change From Baseline in Hip BMD at Week 48
Outcome Time Frame
Baseline, Week 96
Outcome Measure
Percentage Change From Baseline in Hip BMD at Week 96
Outcome Time Frame
Baseline, Week 144
Outcome Measure
Percentage Change From Baseline in Hip BMD at Week 144
Outcome Time Frame
Baseline, Week 48
Outcome Measure
Percentage Change From Baseline in Spine BMD at Week 48
Outcome Time Frame
Baseline, Week 96
Outcome Measure
Percentage Change From Baseline in Spine BMD at Week 96
Outcome Time Frame
Baseline, Week 144
Outcome Measure
Percentage Change From Baseline in Spine BMD at Week 144
Outcome Description
The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit.
Outcome Time Frame
Baseline, open-label Week 48
Outcome Measure
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm
Outcome Description
The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.
Outcome Time Frame
Baseline, open-label Week 48
Outcome Measure
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm
Outcome Description
The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit.
Outcome Time Frame
Baseline, open-label Week 96
Outcome Measure
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm
Outcome Description
The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.
Outcome Time Frame
Baseline, open-label Week 96
Outcome Measure
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm
Outcome Time Frame
Baseline, open-label Week 48
Outcome Measure
Change From Baseline in CD4+ Cell Count at Week 48 Open-Label
Outcome Time Frame
Baseline, open-label Week 96
Outcome Measure
Change From Baseline in CD4+ Cell Count at Week 96 Open-Label
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Robert Grossberg
Investigator Email
rgrossbe@montefiore.org
Investigator Phone
718-920-5276
MeSH Terms
ABACAVIR, DOLUTEGRAVIR, AND LAMIVUDINE DRUG COMBINATION
BICTEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE, DRUG COMBINATION