Overview

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.