Human Immunodeficiency Virus (HIV-1) Infections MedDRA version: 16.0 Level: LLT Classification code 10020192 Term: HIV-1 System Organ Class: 100000004862
Conditions
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cohort 1 (Treatment Naïve) Subjects who are treatment naïve must meet the following inclusion criteria: - Plasma HIV-1 RNA levels = 1,000 copies/mL at screening - Screening genotype report provided by Gilead Sciences must show sensitivity to FTC and TDF - No prior use of any approved or investigational antiretroviral drug for any length of time Cohort 2 (Pharmacoenhancer Switch) Subjects who are treatment experienced must meet the following inclusion criteria: - Subjects must be receiving ATV 300 mg/RTV 100 mg plus 2 NRTIs OR DRV 800 mg/RTV 100 mg plus 2 NRTIs for at least 6 months prior to screening - Plasma HIV-1 RNA concentrations at undetectable levels (according to the local assay being used) in the 6 months preceding the screening visit and have HIV-1 RNA 5 × ULN will remain eligible if serum lipase is = 5 × ULN) - Females of childbearing potential (as defined in Section 7.8) must agree to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be non-heterosexually active, practice sexual abstinence or have a vasectomized partner) from screening throughout the duration of study treatment and for 30 days following the last dose of study drug. — Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing — Female subjects who have stopped menstruating for = 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range - Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 30 days following discontinuation of investigational medicinal product. A highly effective method of contraception is defined as two separate forms of contraception, one of which must be an effective barrier method, or male subjects must be non-heterosexually active, practice sexual abstinence, or be vasectomized. - Age = 18 years Are the trial subjects under 18? no Number of subjects for this age
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in (or may be discontinued from) this study: - A new AIDS-defining condition (excluding CD4 cell count and percentage criteria) diagnosed within the 30 days prior to screening (refer to Appendix 6) - Subjects receiving drug treatment for Hepatitis C, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study - Subjects experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.) - Females who are breastfeeding - Positive serum pregnancy test (female of childbearing potential) - Have an implanted defibrillator or pacemaker - Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance - A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline and must not be anticipated to require systemic therapy during the study. - Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline - Subjects receiving ongoing therapy with any of the medications in the table presented in section 4.3 of the protocol, including drugs not to be used with EVG, COBI, FTC, TDF, ATV, DRV (refer to the individual agents Prescribing Information); or subjects with any known allergies to the excipients of EVG/COBI/FTC/TDF STR, COBI tablets, atazanavir capsules or darunavir tablets or contraindicated for the 2 NRTIs as part of the Cohort 2 regimen. - Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of COBI-containing regimens on renal parameters at Week 24;Secondary Objective: - To evaluate the safety and tolerability of COBI-containing regimens - To evaluate the long term effect of COBI-containing regimens on renal parameters - To measure the proportion of subjects achieving virologic response at Weeks 24, 48 and 96 (HIV-1 RNA < 50 copies/mL, snapshot analysis);Primary end point(s): Estimated GFR - Creatinine clearence - Cystatin C clearence True GFR - Iohexol clearence Other urinary and serum markers of renal tubular disfunction;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Virologic response - HIV-1 RNA < 50 copies/mL;Timepoint(s) of evaluation of this end point: Weeks 24, 48 and 96 | — |
Countries
Austria, Canada, Dominican Republic, Mexico, Puerto Rico, United Kingdom, United States
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd
Outcome results
None listed