A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection

Gilead Sciences

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Tenofovir disoproxil fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002453

GS-99-908

283C

Details and patient eligibility

About

This study allows patients who need a new anti-HIV treatment to take tenofovir disoproxil fumarate (tenofovir DF), an experimental drug. This study also looks at any side effects the drug causes.

Full description

HIV-1-infected patients who are currently receiving stable antiretroviral therapy add tenofovir DF to their regimen. Study participation lasts for approximately 48 weeks. Interested patients should contact their physicians.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive.
• Have a viral load greater than or equal to 10,000 copies/ml.
• Have a CD4 count less than or equal to 50 cells/mm3, or have a CD4 count greater than 50 and no more than 200 cells/mm3 with an opportunistic (AIDS-related) infection within 90 days of study entry. (Patients with a CD4 count above 200 cells/mm3 may be considered depending on drug supply.)
• Are at least 18 years old.
• Agree to use barrier methods of birth control (such as condoms) while on the study and for 30 days afterward.
• Have a life expectancy of at least one year.

Exclusion Criteria

You will not be eligible for this study if you:

• Have a history of a serious kidney or bone disease.
• Have severe nausea, vomiting, or trouble taking medications by mouth.
• Are pregnant or breast-feeding.
• Abuse alcohol or other substances that your doctor thinks would interfere with taking this medicine.
• Are taking any medicines that interfere with kidney functions.