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A Study of Delavirdine Used Together with Other Anti-HIV Drugs in HIV-Infected Patients



A Study of Delavirdine Used Together with Other Anti-HIV Drugs in HIV-Infected Patients

For Condition: HIV Infections
Status: Completed
Sponsor(s): Pharmacia and Upjohn ,
Synopsis: 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).
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 14 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 160

Location and Contact Information:

Pharmacia & Upjohn
Peapack,  New Jersey,  07977
United States
 


Additional Information:
Study ID Numbers:  228F;  0074
Study Start Date: 
Record last reviewed: January 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002401

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4. Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members

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