Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed

HIV-1 Infection Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603120
• Other study ID #: GS-US-380-1844
• Secondary ID: 2015-004025-14
• Status: Completed
• Phase: Phase 3
• Start date: November 11, 2015
• Est. completion date: October 23, 2019

Study information

• Verified date: October 2020
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 567
• Est. completion date: October 23, 2019
• Est. primary completion date: May 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Estimated glomerular filtration rate = 50 mL/min (= 0.83 mL/sec).

• Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for = 3 months prior to the screening visit.

• HIV ribonucleic acid (RNA) < 50 copies/mL at the screening visit.

• Currently on a stable regimen for = 3 months preceding the screening visit with documented plasma HIV-1 RNA < 50 copies/mL for = 3 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is = 50 copies/mL).

• Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), DTG, ABC or 3TC.

Key Exclusion Criteria:

• Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.

• Active tuberculosis infection.

• Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).

• Females who are pregnant.

• Females who are breastfeeding.

• Acute hepatitis in the 30 days prior to study entry.

• Chronic Hepatitis B Virus (HBV) infection.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Drug:
• ABC/DTG/3TC
600/50/300 mg FDC tablets administered orally once daily without regard to food
• B/F/TAF
50/200/25 mg FDC tablets administered orally once daily without regard to food
• ABC/DTG/3TC Placebo
Tablets administered orally once daily without regard to food
• B/F/TAF Placebo
Tablets administered orally once daily without regard to food

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Italy,  Puerto Rico,  Spain,  United Kingdom, 

References & Publications (2)

Andreatta K, Willkom M, Martin R, Chang S, Wei L, Liu H, Liu YP, Graham H, Quirk E, Martin H, White KL. Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance i — View Citation

Molina JM, Ward D, Brar I, Mills A, Stellbrink HJ, López-Cortés L, Ruane P, Podzamczer D, Brinson C, Custodio J, Liu H, Andreatta K, Martin H, Cheng A, Quirk E. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Virologic Failure (HIV-1 RNA = 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm	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.	Week 48
Secondary	Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm	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.	Week 48
Secondary	Change From Baseline in CD4+ Cell Count at Week 48		Baseline; Week 48
Secondary	Spine Bone Mineral Density (BMD) at Baseline		Baseline
Secondary	Percentage Change From Baseline in Spine BMD at Week 48		Baseline; Week 48
Secondary	Hip Bone Mineral Density at Baseline		Baseline
Secondary	Percentage Change From Baseline in Hip BMD at Week 48		Baseline; Week 48