HIV Infections
Conditions
Keywords
HIV-1, Treatment Naive, Treatment Experienced
Brief summary
The purpose of this study is to provide long-term clinical safety and efficacy data for tenofovir disoproxil fumarate and emtricitabine in HIV-infected patients experiencing various degrees of renal impairment.
Detailed description
The primary objective of this study is as follows: * To evaluate the safety and tolerability of tenofovir following administration of tenofovir disoproxil fumarate 300 mg for 48 weeks in HIV-infected patients experiencing various degrees of renal impairment. The secondary objectives of this study are as follows: * To evaluate the safety and tolerability of emtricitabine following administration of emtricitabine 200 mg for 48 weeks in HIV-infected patients experiencing various degrees of renal impairment. * To evaluate the efficacy of tenofovir disoproxil fumarate in combination with emtricitabine in renally-impaired HIV-infected patients. * To evaluate the pharmacokinetics of tenofovir and emtricitabine in renally-impaired HIV-infected patients.
Interventions
DRUGTruvada (tenofovir DF + emtricitabine)
DRUGEmtriva (emtricitabine)
DRUGViread (tenofovir DF)
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients must meet all of the following inclusion criteria to be eligible for participation in the study. * HIV-1 infection * Either antiretroviral therapy-naive requiring antiretroviral treatment with HIV-1 RNA greater than 400 copies/mL or antiretroviral therapy-experienced on a stable antiretroviral regimen for at least 3 mos. with HIV-1 RNA less than or equal to 50 copies/mL at screening. * No active opportunistic infection within 45 days prior to baseline. * Able to understand and sign the informed consent form and comply with the study. * Stable renal impairment within the four defined groups for at least 3 mos., based on creatinine clearance (Cockcroft-Gault method).
Exclusion criteria
Patients who meet any of the following are not to be enrolled in this study. * Women who are pregnant or breastfeeding * Fanconi syndrome or multiple myeloma, tertiary hyperparathyroidism, malignancy (with the exception of basocellular carcinoma) or myeloproliferative disorder. * Women of childbearing potential who are unwilling to use an effective contraceptive method during the study * Contraindications to tenofovir DF, emtricitabine or efavirenz * Undergoing treatment for tuberculosis * Using atazanavir * Prior history of mutation M184V, K65R or T69 insertion * Z-score on pre-baseline DEXA scan less than -2.5 * The following laboratory values within 30 days prior to study entry: \*absolute neutrophil count (ANC) less than 750/mm3, \*hemoglobin less than 9.0 g/dL, \*platelet count less than 50,000/mm3, \*AST (SGOT) or ALT (SGPT) less than 5 x ULN and \*CD4 cell count less than 100/mm3. * Use of nephrotoxic agents or competitors with renal excretions, including aminoglycoside antibiotics, intravenous amphotericin B, cidofovir, cisplatin, foscarnet, intravenous pentamidine, probenecid or other agents with significant nephrotoxic potential * Clinically significant cardiac, pulmonary or gastrointestinal disorder * Alcohol or drug abuse that could hinder compliance with the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HIV-1 infection | — |
Secondary
| Measure | Time frame |
|---|---|
| HIV-1 infection in renally impaired HIV infected patients | — |
Countries
United States
Outcome results
None listed