A Study to Compare the Effectiveness of a Four Drug Anti-HIV Regimen Given Alone or in Combination With GM-CSF or IL-12 to HIV-Positive Patients

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

Keywords

ClinConnect Summary

Potent antiretroviral therapies that suppress HIV replication have permitted mathematical modeling of the dynamics of HIV infection and clearance by measurement of the decay of viral load in plasma. When de nova infection is blocked by antiretroviral therapy, the viral load decreases exponentially after a short initial lag time ("shoulder"). This rapid decline is followed by a slower second-phase decay. The intent of this study is to utilize four antiretroviral agents (zidovudine, lamivudine, nevirapine, indinavir) and very frequent measures of viral load to explore the drug-specific kineti...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• You may be eligible for this study if you:
• • Are HIV-positive.
• • Have a CD4 cell count greater than or equal to 300 cells/ml within 30 days prior to study entry.
• • Have a plasma viral load (level of HIV in the blood) of greater than or equal to 20,000 copies/ml within 30 days of study entry.
• • Are at least 18 years old.
• • Agree to practice abstinence or use effective methods of birth control during the study.
• • Exclusion Criteria
• You will not be eligible for this study if you:
• • Have taken anti-HIV medication for more than 7 days.
• • Have had known seroconversion within 6 months prior to study entry.
• • Have any infection requiring treatment within 30 days prior to study entry.
• • Have had a fever for 7 days in a row during the 30 days before study entry.
• • Have cancer that requires chemotherapy.
• • Are pregnant or breast-feeding.
• • Are taking certain medications.

Trial Officials