The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients
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
2 other identifiers
interventional
N/A
1 country
19
Brief 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.
Trial Health
Trial Health Score
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19 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
July 1, 2001
December 19, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (19)
East Bay AIDS Ctr
Berkeley, California, 94705, United States
Tower ID Med Associates
Los Angeles, California, 90048, United States
Pacific Horizons Med Group
San Francisco, California, 94115, United States
Harbor - UCLA Med Ctr
Torrance, California, 90502, United States
Univ of Colorado / Health Science Ctr
Denver, Colorado, 80262, United States
Physicans Home Service
Washington D.C., District of Columbia, 20037, United States
Steinhart Medical Associates
Miami, Florida, 33133, United States
Dr Gerald Pierone Jr
Vero Beach, Florida, 32960, United States
Northstar Med Clinic
Chicago, Illinois, 60657, United States
CRI New England
Brookline, Massachusetts, 02146, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
Univ of Rochester Med Ctr
Rochester, New York, 14642, United States
Research & Education Group
Portland, Oregon, 97209, United States
Hershey Med Ctr
Hershey, Pennsylvania, 17033, United States
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15221, United States
Roger Williams Med Ctr
Providence, Rhode Island, 02908, United States
Southwest Infectious Diseases Associates
Dallas, Texas, 75246, United States
Thomas Street Clinic
Houston, Texas, 77009, United States
Dr Philip C Craven
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 19, 2000
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 2001-07