Tenofovir DF (Disoproxil Fumarate) in Combination With Emtricitabine in HIV-1 Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00106379
- Lead Sponsor
- Gilead Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
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).
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method HIV-1 infection
- Secondary Outcome Measures
Name Time Method HIV-1 infection in renally impaired HIV infected patients
Trial Locations
- Locations (4)
Gary Richmond, MD
🇺🇸Fort Lauderdale, Florida, United States
Treasure Coast Infectious Disease Consultants
🇺🇸Vero Beach, Florida, United States
Fernando Garcia, MD
🇺🇸Harlingen, Texas, United States
Ronald Reisler, MD
🇺🇸Baltimore, Maryland, United States