This study will test an experimental drug called GS-9883/emtricitabine/tenofovir alafenamide (GS-9883/F/TAF) fixed dose combination (FDC) for the treatment of HIV-1 infection. The purpose of this study is to test safety and to test whether GS-9883/F/TAF as a FDC works as well as the FDC drug containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) (trade name Triumeq). The study will also test whether GS-9883/F/TAF maintains the control of HIV-1 infection effectively compared to ABC/DTG/3TC.
- Conditions
- Human Immunodeficiency Virus (HIV-1) InfectionMedDRA version: 18.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-004024-54-ES
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 631
1) The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
2) Age >= 18 years
3) Antiretroviral treatment naïve (<= 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for PrEP (pre-exposure prophylaxis) or PEP (post-exposure prophylaxis), up to one month prior to screening
4) Plasma HIV-1 RNA levels >= 500 copies/mL at screening
5) Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)
6) Adequate renal function: Estimated glomerular filtration rate >= 50 mL/min (>= 0.83 mL/sec) according to the Cockcroft-Gault formula
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 from screening, throughout the duration of the study period, and for 30 days following the last dose of study drug.
a) Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least 3 months prior to study drug dosing.
12) Male subjects who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception 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) Screening genotype report provided by Gilead Sciences must show sensitivity to FTC, TFV, 3TC, and ABC
16) Negative screening test for HLA-B*5701 allele provided by Gilead Sciences
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 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
1) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
2) Subjects experiencing decompensated cirrhosis (e.g, ascites, encephalopathy, or variceal bleeding)
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 (e.g, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
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. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study
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 ABC/DTG/3TC FDC tablets
10) Females who are pregnant (as confirmed by positive serum pregnancy test)
11) Females who are breastfeeding
12) Subjects receiving ongoing therapy with any protocol-specified medications including drugs not to be used with FTC, TAF, GS-9883, DTG, ABC and 3TC
13) Acute hepatitis in the 30 days prior to study entry
14) Chronic Hepatitis B Virus (HBV) infection, as determined by either:
a) Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit
b) Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit
15) Active tuberculosis infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method