Status:
COMPLETED
Tenofovir DF (Disoproxil Fumarate) in Combination With Emtricitabine in HIV-1 Patients
Lead Sponsor:
Gilead Sciences
Conditions:
HIV Infections
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 i...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00106379
Start Date
October 1 2004
End Date
January 1 2007
Last Update
February 2 2010
Active Locations (4)
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1
Gary Richmond, MD
Fort Lauderdale, Florida, United States, 33316
2
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States, 32960
3
Ronald Reisler, MD
Baltimore, Maryland, United States, 21201
4
Fernando Garcia, MD
Harlingen, Texas, United States, 78550