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

Status unconfirmed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00007436

Run by

Gilead Sciences

Last updated by the study team

2005-06-24

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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