The Safety and Effectiveness of MK-639 and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
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|ClinicalTrials.gov Identifier: NCT00002443|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Merck Sharp & Dohme Corp.
Information provided by:
NIH AIDS Clinical Trials Information Service
To compare the effects on CD4 counts and safety of MK-639 (indinavir, IDV) and AZT administered concomitantly to MK-639 alone and AZT alone in HIV-1 seropositive patients.
|Condition or disease||Intervention/treatment|
|HIV Infections||Drug: Indinavir sulfate Drug: Zidovudine|
Patients are randomized to 1 of 3 groups for 12 months of treatment. Group 1 receives MK-639 plus AZT. Group 2 receives MK-639 alone. Group 3 receives AZT alone. Safety and tolerability are assessed by the incidence of clinical and laboratory adverse experiences. Blood and urine samples are collected for safety assessment and to determine CD4 cell counts and serum viral RNA levels. If therapy with MK-639 alone or with AZT is found to be generally safe and clinically efficacious, patients who have completed the study will have the opportunity to continue in an extension study protocol on a treatment regimen including MK-639.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||780 participants|
|Official Title:||Twelve-Month Study in HIV-1 Seropositive Retroviral-Naive Patients to Compare the Safety and Efficacy of MK-639 and Zidovudine (AZT) Administered Concomitantly to MK-639 Alone and Zidovudine (AZT) Alone|
|Estimated Study Completion Date :||January 1996|
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