This trial is active, not recruiting.

Condition hiv infections
Treatment tenofovir disoproxil fumarate
Phase phase 3
Sponsor Gilead Sciences
Trial identifier NCT00007436, 283F, GS-99-910


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Primary purpose treatment

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

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
Description Patients take tenofovir DF in combination with other antiretrovirals.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by NIH AIDS Clinical Trials Information Service.