Tenofovir DF (Disoproxil Fumarate) in Combination With Emtricitabine in HIV-1 Patients

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

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