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

Launched by GILEAD SCIENCES · Aug 30, 2001

Keywords

ClinConnect Summary

Recent studies indicate that the use of triple-combination therapy, in particular the combinations of reverse transcriptase inhibitors and a protease inhibitor, can result in a significant decrease in plasma HIV-1 RNA levels and an increase in CD4 cell count. Continued follow-up of patients taking triple-combination drug regimens has in some cases demonstrated sustained suppression of plasma HIV-1 RNA levels for up to 18 months. Furthermore, despite the potent antiviral effect of some triple combinations, a percentage of patients continue to have measurable levels (more than 500 copies/ml) ...

Gender

ALL

Eligibility 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.