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

NCT ID: NCT00000861

Last Updated: 2021-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1900 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 1997-03-31

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.

Conditions

HIV Infections

Keywords

Drug Administration Schedule; HIV Protease Inhibitors; CD4 Lymphocyte Count; Indinavir; RNA, Viral; Anti-HIV Agents; Viral Load

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Indinavir sulfate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Topical and/or antifungal agents, except ketoconazole.
• Treatment, maintenance, or chemoprophylaxis with approved agents for OIs will be given as clinically indicated.
• Clinically indicated antibiotics, unless excluded.
• Systemic corticosteroid use for <21 days for acute problems is permitted as clinically indicated. However, chronic systemic corticosteroid use should be avoided.
• Recombinant erythropoietin (rEPO) and granulocyte-colony stimulating factor (G-CSF, filgrastim).
• Didanosine (ddI).
• Regularly prescribed medications, such as antipyretics, antidepressants, oral contraceptives, megestrol acetate, testosterone, or any other medication.

Patients must have:

• A working diagnosis of HIV infection.
• A CD4+ count between 200 and 500 cells/mm3.
• Signed, informed parental consent if patient is less than 18.

NOTE:

• The DAIDS Clinical Science Research Committee (CSRC) has deemed this protocol appropriate for prisoner enrollment.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following conditions or symptoms are excluded:

Febrile illness with temperature > 38.5 degrees C (101.3 degrees F) within 3 days prior to study entry.

Concurrent Medication:

Excluded:

• Non-nucleoside reverse transcriptase inhibitors.
• Protease inhibitors except IDV.
• Rifabutin and rifampin.
• Ketoconazole.
• Terfenadine, astemizole, cisapride, triazolam and midazolam.

Patients with any of the following prior conditions are excluded:

• History of prior saquinavir (SQV) therapy for more than 14 days.
• History of any prior protease inhibitor therapy other than SQV.
• History of serious opportunistic infection.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saravolatz L

Role: STUDY_CHAIR

Crane L

Role: STUDY_CHAIR

Mayers D

Role: STUDY_CHAIR

Locations

Community Consortium of San Francisco

San Francisco, California, United States

Denver CPCRA / Denver Public Hlth

Denver, Colorado, United States

Veterans Administration Med Ctr / Regional AIDS Program

Washington D.C., District of Columbia, United States

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

AIDS Research Alliance - Chicago

Chicago, Illinois, United States

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

New Orleans, Louisiana, United States

Comprehensive AIDS Alliance of Detroit

Detroit, Michigan, United States

Henry Ford Hosp

Detroit, Michigan, United States

Southern New Jersey AIDS Cln Trials / Dept of Med

Camden, New Jersey, United States

North Jersey Community Research Initiative

Newark, New Jersey, United States

Harlem AIDS Treatment Group / Harlem Hosp Ctr

New York, New York, United States

Portland Veterans Adm Med Ctr / Rsch & Education Grp

Portland, Oregon, United States

Philadelphia FIGHT

Philadelphia, Pennsylvania, United States

Richmond AIDS Consortium

Richmond, Virginia, United States

Countries

United States

References

Spector SA, Barker C, Buhles W, Feinberg J, Montague P, Weingeist T, DeArmond B. A randomized, controlled study of immediate vs deferred ganciclovir therapy in AIDS patients with cytomegalovirus peripheral retinitis. Int Conf AIDS. 1991 Jun 16-21;7(1):44 (abstract no MB86)

Reference Type: BACKGROUND

Other Identifiers

11591

Identifier Type: REGISTRY

Identifier Source: secondary_id

CPCRA 041

Identifier Type: -

Identifier Source: org_study_id