A clinical research study to see how six medications that are approved for the treatment of HIV-1 infection affect the kidneys. The six approved medications are Stribild, Truvada, Atripla, Reyataz, Norvir, and Kivexa. Both the patient and the investigator will know which medication the patient is receiving. This is a randomised (by chance, like the flip of a coin) study

Phase 1

• Conditions: Human Immunodeficiency Virus, Type 1 (HIV-1) Infection; MedDRA version: 17.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-002095-93-ES
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-25
• Study Completion: 2016-02-17
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• The ability to understand and sign a written informed consent form
(ICF)
• Treatment naïve
• Plasma HIV-1 RNA levels = 5,000 copies/mL at screening
• CD4 cell count > 200 cells/µL
• Screening genotype report provided by the site must show sensitivity
to FTC, TDF, EFV, ABC, 3TC, ATV and absence of study drug resistance
mutations that include K65R, K70E and M184V in RT.
• Estimated GFR = 70 mL/min according to the Cockcroft Gault formula
for creatinine clearance (CLcr).
• Hepatic transaminases (AST and ALT) = 5 × upper limit of normal
(ULN)
• Total bilirubin = 1.5 mg/dL (<=26umol/L), or normal direct bilirubin
• Adequate hematologic function
• Serum amylase = 5 × ULN (patients with serum amylase > 5 × ULN
will remain eligible if serum lipase is = 5 × ULN)
• Normal ECG (or if abnormal, determined by the Investigator to be not
clinically significant)
• A female subject is eligible to enter the study if it is confirmed that
she is (as defined in the protocol): not pregnant or non-lactating; of nonchildbearing
potential; of childbearing potential and agrees to utilize
highly effective contraception methods or be non heterosexually active
or practice sexual abstinence from screening throughout the duration of
study treatment and for 90 days if taking EFV/FTC/TDF or for 30 days
for all other study drugs following the last study drug dose.
- (Female patients 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)
• Male patients must agree to utilize a highly effective method of
contraception during heterosexual intercourse or be non heterosexually
active, or practice sexual abstinence from first dose throughout the
study period and for 90 days if taking EFV/FTC/TDF or for 30 days for all
other study drugs following the last study drug dose.
• Male patients must agree to refrain from sperm donation from first
dose until at least 90 days if taking EFV/FTC/TDF or for 30 days for all
other study drugs following the last study drug dose.
• 18- 55 years of age, inclusive
• Body mass index (BMI) of 19 = BMI = 30 kg/m2 and body weight =
40 kg
• Life expectancy = 1 year
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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? Patients who are HLA-B*5701 allele positive
? A new AIDS-defining condition diagnosed within the 30 days prior to screening
? Hepatitis B surface antigen (HBsAg) positive
? Hepatitis C virus (HCV) antibody positive and HCV RNA detectable
? Patients experiencing decompensated cirrhosis (eg, ascites, encephalopathy, etc.)
? Females who are breastfeeding
? Positive serum pregnancy test (females 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. Patients with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 Visit 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 Day 1 Visit
? 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 dosing requirements
? Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial
? Known hypersensitivity to the study drugs, the metabolites, or formulation excipients
? Previous reaction to contrast media or sensitivity to iodine or a known clinical hypersensitivity including a history of bronchial asthma, hay fever, or food allergies.
? Patients receiving ongoing therapy with any drugs not to be used with Stribild, Truvada, Atripla, Kivexa, and ritonavir-boosted atazanavir (Reyataz)

Study & Design

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