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

NCT ID: NCT00007436

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Patients take tenofovir DF in combination with other antiretrovirals.

Conditions

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HIV Infections

Keywords

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HIV-1 Drug Therapy, Combination Reverse Transcriptase Inhibitors Anti-HIV Agents 9-(2-phosphonylmethoxypropyl)adenine

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Tenofovir disoproxil fumarate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Locations

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East Bay AIDS Ctr

Berkeley, California, United States

Site Status

Tower ID Med Associates

Los Angeles, California, United States

Site Status

Pacific Horizons Med Group

San Francisco, California, United States

Site Status

Harbor - UCLA Med Ctr

Torrance, California, United States

Site Status

Univ of Colorado / Health Science Ctr

Denver, Colorado, United States

Site Status

Physicans Home Service

Washington D.C., District of Columbia, United States

Site Status

Steinhart Medical Associates

Miami, Florida, United States

Site Status

Dr Gerald Pierone Jr

Vero Beach, Florida, United States

Site Status

Northstar Med Clinic

Chicago, Illinois, United States

Site Status

CRI New England

Brookline, Massachusetts, United States

Site Status

Univ of Minnesota

Minneapolis, Minnesota, United States

Site Status

Univ of Rochester Med Ctr

Rochester, New York, United States

Site Status

Research & Education Group

Portland, Oregon, United States

Site Status

Hershey Med Ctr

Hershey, Pennsylvania, United States

Site Status

Anderson Clinical Research

Pittsburgh, Pennsylvania, United States

Site Status

Roger Williams Med Ctr

Providence, Rhode Island, United States

Site Status

Southwest Infectious Diseases Associates

Dallas, Texas, United States

Site Status

Thomas Street Clinic

Houston, Texas, United States

Site Status

Dr Philip C Craven

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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GS-99-910

Identifier Type: -

Identifier Source: secondary_id

283F

Identifier Type: -

Identifier Source: org_study_id