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The Safety and Effectiveness of MK-639 and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

2014-08-27 03:59:08 | BioPortfolio

Summary

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.

Description

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 Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

HIV Infections

Intervention

Indinavir sulfate, Zidovudine

Status

Completed

Source

NIH AIDS Clinical Trials Information Service

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:59:08-0400

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Medical and Biotech [MESH] Definitions

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