HIV Infections
Conditions
Keywords
HIV-1, Zidovudine, HIV Protease Inhibitors, Lamivudine, Indinavir, RNA, Viral, Delavirdine, Reverse Transcriptase Inhibitors, Viral Load
Brief summary
The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients. The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).
Detailed description
In this open-label pilot study, patients are randomized to 1of the following 4 arms for 24 weeks: Arm 1 (40 patients): DLV plus ZDV plus IDV. Arm 2 (40 patients): DLV plus IDV plus 3TC\*. Arm 3 (40 patients): DLV plus ZDV plus IDV plus 3TC. Arm 4 (40 patients): ZDV plus IDV plus 3TC. * Dose determined by body weight. Patients may opt to continue on study for 24 additional weeks at the discretion of the investigator.
Interventions
Sponsors
Pharmacia and Upjohn
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Prior Medication: Allowed: Less than 1 month prior treatment with zidovudine.
Exclusion criteria
Prior Medication: Excluded: * Prior indinavir. * Prior lamivudine. * Prior protease inhibitors. * Prior non-nucleoside reverse transcriptase inhibitors. * 1 month or more prior zidovudine. 1\. HIV-1 positive. * CD4 coun tis above 50. * HIV-1 RNA levels greater than 20,000.
Countries
United States
Outcome results
None listed