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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Anti-Retroviral Agents; Tenofovir

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.