The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients
A Randomized Trial of Immediate Versus Deferred Indinavir in Addition to Background Antiretroviral Therapy in HIV-Infected Patients With CD4+ Cell Counts Between 200 and 500/mm3 and Plasma HIV RNA Levels >= 10,000 Copies/ml
2 other identifiers
interventional
1,900
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
March 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 28, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Community Consortium of San Francisco
San Francisco, California, 94110, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507, United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112, United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, 48201, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, 08103, United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 972109951, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
Richmond AIDS Consortium
Richmond, Virginia, 23298, United States
Related Publications (1)
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)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Saravolatz L
- STUDY CHAIR
Crane L
- STUDY CHAIR
Mayers D
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
March 1, 1997
Last Updated
October 28, 2021
Record last verified: 2021-10