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NCT00007436 Clinical Trial

The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients

HIV Infections Clinical Trial

Official title:
A Phase 3, Open-Label, Multicenter Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00007436
Other study ID # 283F
Secondary ID GS-99-910
Status Active, not recruiting
Phase Phase 3
First received December 19, 2000
Last updated June 23, 2005

Study information
Verified date July 2001
Source NIH AIDS Clinical Trials Information Service
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 evaluate the safety of tenofovir disoproxil fumarate (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated in other tenofovir DF studies (GS-98-902 or GS-99-907), are able to tolerate the drug at different doses, and may benefit from having tenofovir DF treatment.

Description:

Patients take tenofovir DF in combination with other antiretrovirals.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria

Patients may be eligible for this study if they:

- Have completed another study on tenofovir DF without toxicity.

- Are willing to use intrauterine or effective barrier methods of birth control, both men and women, during the study and for 30 days following tenofovir DF treatment.

Exclusion Criteria

Patients will not be eligible for this study if they:

- Are taking drugs that may damage the kidney (nephrotoxic) including aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, vancomycin, and oral or IV ganciclovir.

- Are taking agents that affect kidney function, such as probenecid.

- Are receiving systemic chemotherapy.

- Are taking systemic corticosteroids.

- Are taking experimental drugs except those that are approved by Gilead.

- Are currently participating in the GS-99-908 or GS-00-912 (expanded access) studies.

- Are pregnant or breast-feeding.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tenofovir disoproxil fumarate

Locations
Country Name City State
United States East Bay AIDS Ctr Berkeley California
United States CRI New England Brookline Massachusetts
United States Northstar Med Clinic Chicago Illinois
United States Southwest Infectious Diseases Associates Dallas Texas
United States Univ of Colorado / Health Science Ctr Denver Colorado
United States Hershey Med Ctr Hershey Pennsylvania
United States Thomas Street Clinic Houston Texas
United States Tower ID Med Associates Los Angeles California
United States Steinhart Medical Associates Miami Florida
United States Univ of Minnesota Minneapolis Minnesota
United States Anderson Clinical Research Pittsburgh Pennsylvania
United States Research & Education Group Portland Oregon
United States Roger Williams Med Ctr Providence Rhode Island
United States Univ of Rochester Med Ctr Rochester New York
United States Pacific Horizons Med Group San Francisco California
United States Dr Philip C Craven Tacoma Washington
United States Harbor - UCLA Med Ctr Torrance California
United States Dr Gerald Pierone Jr Vero Beach Florida
United States Physicans Home Service Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

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