Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations

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

Summary

The purpose of this study is to see if it is safe and effective to give adefovir plus other anti-HIV drugs to HIV-infected patients who have failed other anti-HIV drug combinations. This study will try to make adefovir available to all AIDS patients who need it.

Some patients do not respond to anti-HIV drug combinations, even when different combinations are tried. Adefovir may be able to help these patients fight HIV.

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

Details

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

Criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive.

• Have a CD4 cell count of 50 cells/mm3 or less within the past 2 months.

• Have a viral load (level of HIV in the body) of 30,000 copies/ml or more within the past 2 months.

• Are at least 13 years old (need consent of parent or guardian if under 18).

• Have failed to respond to an anti-HIV drug combination that included at least 2 nucleoside reverse transcriptase inhibitors and at least 1 protease inhibitor (PI).

• Do not have any other anti-HIV treatment options left.

• Agree to use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

• Have certain serious medical conditions that would prevent you from completing the study, including serious kidney disorders.

• Have taken certain medications, including certain treatments for opportunistic (HIV-related) diseases.

• Are pregnant or breast-feeding.