This study will test an experimental drug called GS-9883/emtricitabine/tenofovir alafenamide (GS-9883/F/TAF) for the treatment of HIV-1 infection The purpose of this study is to test the effectiveness of switching to GS-9883/F/TAF versus continuing on a regimen containing boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in virologically suppressed HIV-1 infected adult subjects (HIV-1 RNA < 50 copies/mL)

Phase 1

• Conditions: Human Immunodeficiency Virus (HIV-1) Infection; MedDRA version: 18.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-004011-20-ES
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-30
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 520

Inclusion Criteria

1) The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
2) Aged 18 years or older
3) Currently receiving antiretroviral regimen consisting of ritonavir or cobicistat boosted ATV or DRV plus either FTC/TDF or ABC/3TC for 6 months or more preceding the screening visit
4) HIV RNA < 50 copies/mL at the screening visit
5) Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)
6) Adequate renal function
7) Hepatic transaminases (AST and ALT) <= 5 x upper limit of normal (ULN)
8) Total bilirubin <= 1.5 mg/dL (<= 26 umol/L), or normal direct bilirubin
9) Adequate hematologic function (absolute neutrophil count >= 750/mm3 (>= 0.75 GI/L); platelets >= 50,000/mm3 (>= 50 GI/L); hemoglobin >= 8.5 g/dL (>= 85 g/L))
10) Serum amylase <= 5 × ULN (subjects with serum amylase > 5 × ULN will remain eligible if serum lipase is <= 5 × ULN)
11) Females of childbearing potential must agree to utilize protocol recommended highly effective contraceptive methods or be non-heterosexually active or practice sexual abstinence (as defined in Appendix 6) from screening, throughout the duration of the study period, and for 30 days following the last dose of study drug
12) Male subjects who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception (as described in Appendix 6) throughout the study period and for 90 days following the last dose of study drug
13) Male subjects must agree to refrain from sperm donation from first study drug dose until at least 90 days following the last study drug dose
14) Life expectancy >= 1 year
15) Currently on the first or second antiretroviral regimen with documented plasma HIV-1 RNA < 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is >= 50 copies/mL) for >= 6 months preceding the Screening visit
16) Have no documented or suspected resistance to FTC, TFV, ABC or 3TC, including but not limited to the reverse transcriptase resistance mutations K65R and M184V/I
17) No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 420
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
2) Subjects experiencing decompensated cirrhosis
3) Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study
4) Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
5) A history of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
6) Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
7) Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial
8) Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements
9) Any known allergies to the excipients of GS-9883/F/TAF FDC or ATV, RTV, DRV, COBI, FTC/TDF or ABC/3TC
10) Females who are pregnant (as confirmed by positive serum pregnancy test)
11) Females who are breastfeeding
12) Subjects receiving ongoing therapy with any of the medications listed in Table 5-1 and Table 5-2. Administration of any Prohibited Medication (Table 5-1 and Table 5-2) must be discontinued at least 30 days prior to the Day 1 visit and for the duration of the study.
13) Acute hepatitis in the 30 days prior to study entry
14) Chronic hepatitis B infection in subjects not on a TDF containing regimen
15) Active tuberculosis infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified