HIV Infections
Conditions
Keywords
HIV-1, Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, Indinavir, RNA, Viral, Delavirdine, Reverse Transcriptase Inhibitors
Brief summary
The purpose of this study is to compare the safety and effectiveness of giving HIV-infected patients delavirdine (DLV) plus zidovudine (ZDV) plus 2 doses of indinavir (IDV) or ZDV plus IDV plus lamivudine (3TC). This study also examines how the body processes DLV when it is given in combination with other drugs.
Detailed description
In this multicenter, open-label study, 45 HIV-1-positive patients receive either combination drug therapy with delavirdine (DLV), zidovudine (ZDV), and indinavir (IDV) or combination drug therapy with ZDV, lamivudine (3TC), and IDV. NOTE: Patients are treated for 24 weeks and may opt to continue on study for 24 additional weeks, if HIV-1 RNA is less than 5,000 copies/ml or at the investigator's discretion.
Interventions
Sponsors
Pharmacia and Upjohn
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must have: * HIV-1 positive. * CD4 count above 50. * HIV-1 RNA greater than 20,000. Prior Medication: Allowed: Less than 1 month prior treatment with zidovudine.
Exclusion criteria
Prior Medication: Excluded: * Prior 3TC, protease inhibitors, or non-nucleoside reverse transcriptase inhibitors. * Prior ZDV of greater than 1 month total duration. Prior Treatment: Excluded: * Lamivudine. * Protease inhibitors. * Non-nucleoside reverse transcriptase inhibitors.
Countries
United States
Outcome results
None listed