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

HIV Infections Clinical Trial

Official title:

A Phase 4, Single-Arm Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Tenofovir Disoproxil Fumarate in Combination With Emtricitabine in HIV-1 Infected Patients Experiencing Various Degrees of Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106379
• Other study ID #: GS-104-0235
• Status: Completed
• Phase: Phase 4
• First received: March 23, 2005
• Last updated: February 1, 2010
• Start date: October 2004
• Est. completion date: January 2007

Study information

• Verified date: April 2008
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Truvada (tenofovir DF + emtricitabine)

• Emtriva (emtricitabine)

• Viread (tenofovir DF)

Locations

Country	Name	City	State
United States	Ronald Reisler, MD	Baltimore	Maryland
United States	Gary Richmond, MD	Fort Lauderdale	Florida
United States	Fernando Garcia, MD	Harlingen	Texas
United States	Treasure Coast Infectious Disease Consultants	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV-1 infection
Secondary	HIV-1 infection in renally impaired HIV infected patients

External Links

•   Emtriva website
•   Gilead website
•   Truvada website
•   Viread website