A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Combination antiretroviral therapies using protease inhibitors (PIs) are capable of suppressing plasma HIV RNA to undetectable levels. However, approximately 10% of patients who achieve undetectable viral loads will experience a detectable rise in HIV RNA each year. When HIV replication has been suppressed to very low levels, it may be possible to consolidate antiretroviral therapy into a simpler and potentially less toxic "maintenance" regimen without a PI. Such a regimen would ideally be potent enough to continue to maintain viral suppression but use agents that are better tolerated, more...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• You may be eligible for this study if you:
• • Are at least 13 years old (need consent if under 18).
• • Are HIV-positive.
• • Are taking your first anti-HIV drug regimen, which must include a PI and at least one NRTI (nucleoside reverse transcriptase inhibitor) and have been on this regimen for at least 12 months.
• • Have a viral load less than 400 copies/ml for at least 12 months prior to study entry, and have a viral load less than 50 copies/ml within 60 days of study entry.
• • Have a CD4 cell count of at least 200 cells/mm3 within 60 days of study entry.
• • Are willing to go back on the drugs you are currently on, if necessary.
• • Are willing to use effective methods of birth control during the study and for 3 months after.
• • Exclusion Criteria
• You will not be eligible for this study if you:
• • Have taken ddI, d4T, or HU for more than 2 weeks.
• • Have taken any NNRTI (non-nucleoside reverse transcriptase inhibitor) for more than 7 days.
• • Have ever taken EFV.
• • Have received an HIV vaccine within 30 days prior to study entry.
• • Have an AIDS-related cancer that requires chemotherapy.
• • Have or have had pancreatic disease.
• • Are being treated for a significant illness.
• • Abuse drugs or alcohol.
• • Are pregnant or breast-feeding.
• • Are allergic to any study drugs.
• • Have received certain medications.

Trial Officials