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
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ClinicalTrials.gov Identifier: NCT02607930 |
Recruitment Status :
Completed
First Posted : November 18, 2015
Results First Posted : July 23, 2018
Last Update Posted : March 2, 2022
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Condition or disease | Intervention/treatment | Phase |
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HIV-1 Infection | Drug: ABC/DTG/3TC Drug: B/F/TAF Drug: ABC/DTG/3TC Placebo Drug: B/F/TAF Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 631 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | November 13, 2015 |
Actual Primary Completion Date : | May 9, 2017 |
Actual Study Completion Date : | July 2, 2021 |

Arm | Intervention/treatment |
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Experimental: B/F/TAF
B/F/TAF + ABC/DTG/3TC placebo administered without regard to food for at least 144 weeks.
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Drug: B/F/TAF
50/200/25 mg tablets administered orally, once daily, without regard to food
Other Names:
Drug: ABC/DTG/3TC Placebo Tablets administered orally, once daily |
Active Comparator: ABC/DTG/3TC
ABC/DTG/3TC + B/F/TAF placebo administered without regard to food for at least 144 weeks.
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Drug: ABC/DTG/3TC
600/50/300 milligrams (mg) tablets administered orally, once daily
Other Name: Triumeq® Drug: B/F/TAF Placebo Tablets administered orally, once daily |
Experimental: Open-label Phase B/F/TAF to B/F/TAF
After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.
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Drug: B/F/TAF
50/200/25 mg tablets administered orally, once daily, without regard to food
Other Names:
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Experimental: Open-label Phase ABC/DTG/3TC to B/F/TAF
After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.
|
Drug: B/F/TAF
50/200/25 mg tablets administered orally, once daily, without regard to food
Other Names:
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- Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 48 ]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.
- Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 96 ]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.
- Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 144 ]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.
- Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 48 ]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.
- Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 96 ]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.
- Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 144 ]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.
- Change From Baseline in log10 HIV-1 RNA at Week 48 [ Time Frame: Baseline, Week 48 ]
- Change From Baseline in log10 HIV-1 RNA at Week 96 [ Time Frame: Baseline, Week 96 ]
- Change From Baseline in log10 HIV-1 RNA at Week 144 [ Time Frame: Baseline, Week 144 ]
- Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline, Week 48 ]
- Change From Baseline in CD4+ Cell Count at Week 96 [ Time Frame: Baseline, Week 96 ]
- Change From Baseline in CD4+ Cell Count at Week 144 [ Time Frame: Baseline, Week 144 ]
- Percentage Change From Baseline in Hip BMD at Week 48 [ Time Frame: Baseline, Week 48 ]
- Percentage Change From Baseline in Hip BMD at Week 96 [ Time Frame: Baseline, Week 96 ]
- Percentage Change From Baseline in Hip BMD at Week 144 [ Time Frame: Baseline, Week 144 ]
- Percentage Change From Baseline in Spine BMD at Week 48 [ Time Frame: Baseline, Week 48 ]
- Percentage Change From Baseline in Spine BMD at Week 96 [ Time Frame: Baseline, Week 96 ]
- Percentage Change From Baseline in Spine BMD at Week 144 [ Time Frame: Baseline, Week 144 ]
- Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm [ Time Frame: Baseline, open-label Week 48 ]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.
- Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm [ Time Frame: Baseline, open-label Week 48 ]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.
- Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm [ Time Frame: Baseline, open-label Week 96 ]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.
- Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm [ Time Frame: Baseline, open-label Week 96 ]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.
- Change From Baseline in CD4+ Cell Count at Week 48 Open-Label [ Time Frame: Baseline, open-label Week 48 ]
- Change From Baseline in CD4+ Cell Count at Week 96 Open-Label [ Time Frame: Baseline, open-label Week 96 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607930

Study Director: | Gilead Study Director | Gilead Sciences |
Documents provided by Gilead Sciences:
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT02607930 |
Other Study ID Numbers: |
GS-US-380-1489 2015-004024-54 ( EudraCT Number ) |
First Posted: | November 18, 2015 Key Record Dates |
Results First Posted: | July 23, 2018 |
Last Update Posted: | March 2, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/ |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
Time Frame: | 18 months after study completion |
Access Criteria: | A secured external environment with username, password, and RSA code. |
URL: | https://www.gileadclinicaltrials.com/transparency-policy/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
HIV |
Lamivudine Triumeq Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents |