The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients

Not Applicable

Completed

Brief Summary: The purpose of this study is to evaluate the effect of immediate versus deferred indinavir (IDV) in addition to background therapy on disease progression or death in patients with CD4+ cell counts between 200 and 500 cells/mm3 and plasma HIV RNA levels \>= 10,000 copies/ml.

This study aims to examine two management strategies, immediate versus deferred IDV therapy, for their clinical effects in the context of background antiretroviral (AR) therapy, given according to current clinical practice. There is an urgent need to identify the optimal use of IDV in patient management, since clinical endpoint studies have not been completed in the United States. Since there is little information about the long term durability of clinical effects, and even less information about the timing of the initiation of protease inhibitor therapy, exploring the disease progression and survival impact of immediate versus delayed use of IDV will yield important information to guide clinical decision making for this group of patients.

Detailed Description: This study aims to examine two management strategies, immediate versus deferred IDV therapy, for their clinical effects in the context of background antiretroviral (AR) therapy, given according to current clinical practice. There is an urgent need to identify the optimal use of IDV in patient management, since clinical endpoint studies have not been completed in the United States. Since there is little information about the long term durability of clinical effects, and even less information about the timing of the initiation of protease inhibitor therapy, exploring the disease progression and survival impact of immediate versus delayed use of IDV will yield important information to guide clinical decision making for this group of patients.

Prior to randomization the patient and clinician will determine whether the background therapy will be zidovudine (ZDV) plus lamivudine (3TC) or other background antiretroviral therapy (OBAT). Patients will then be randomized to IDV or matching placebo. AS PER AMENDMENT 06/27/97: The protocol was closed as of 03/25/97, and all patients have been unblinded to their assigned treatment. Patients still on study medication are eligible for the protocol extension. Patients who were randomized to immediate IDV may continue on therapy for up to an additional 4 months. All study therapy, both for those on immediate or delayed therapy, must be discontinued on 10/24/97.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Locations (14): Southern New Jersey AIDS Cln Trials / Dept of Med
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Camden, New Jersey, United States
Veterans Administration Med Ctr / Regional AIDS Program
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Washington, District of Columbia, United States
North Jersey Community Research Initiative
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Newark, New Jersey, United States
Henry Ford Hosp
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Detroit, Michigan, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
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Portland, Oregon, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
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New York, New York, United States
AIDS Research Alliance - Chicago
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Chicago, Illinois, United States
Denver CPCRA / Denver Public Hlth
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Denver, Colorado, United States
Philadelphia FIGHT
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Philadelphia, Pennsylvania, United States
Community Consortium of San Francisco
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San Francisco, California, United States
AIDS Research Consortium of Atlanta
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Atlanta, Georgia, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
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New Orleans, Louisiana, United States
Comprehensive AIDS Alliance of Detroit
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Detroit, Michigan, United States
Richmond AIDS Consortium
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Richmond, Virginia, United States