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

NCT ID: NCT00106379

Last Updated: 2010-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2007-01-31

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.

Conditions

HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Truvada (tenofovir DF + emtricitabine)

Intervention Type: DRUG

Emtriva (emtricitabine)

Intervention Type: DRUG

Viread (tenofovir DF)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Locations

Gary Richmond, MD

Fort Lauderdale, Florida, United States

Treasure Coast Infectious Disease Consultants

Vero Beach, Florida, United States

Ronald Reisler, MD

Baltimore, Maryland, United States

Fernando Garcia, MD

Harlingen, Texas, United States

Countries

United States

Related Links

http://www.truvada.com

Truvada website

http://www.gilead.com

Gilead website

http://www.viread.com

Viread website

http://www.gileadclinicaltrials.com/pdf/GS-104-0235_synopsis.pdf

Study Results

Other Identifiers

GS-104-0235

Identifier Type: -

Identifier Source: org_study_id