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

Gilead Sciences

Status and phase: Unknown; Phase 3

Conditions: HIV Infections

Treatments: Drug: Tenofovir disoproxil fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00007436

283F

GS-99-910

Details and patient eligibility

About

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.

Full description

Patients take tenofovir DF in combination with other antiretrovirals.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.