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Home > "T" Clinical Trials Conditions > The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients  The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients
The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients
For Condition: HIV Infections
Status: Terminated
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 1900
Location and Contact Information:
Overall Study Official:
SaravolatzL, Study Chair,
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, 08103
United States
Richmond AIDS Consortium
Richmond, Virginia, 23298
United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, 48201
United States
Community Consortium of San Francisco
San Francisco, California, 94110
United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507
United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York City, New York, 10037
United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422
United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 972109951
United States
Additional Information:
Study ID Numbers: CPCRA 041;
Study Start Date:
Record last reviewed: April 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000861
Other Hiv Infections Studies:
1. Study of How Indinavir (an Anti-HIV Drug) and Rifabutin (a Drug Used to Treat MAC, an HIV-Associated Disease) Interact in HIV-Positive and HIV-Negative Adults
2. A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy
3. Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals
4. Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.
5. RESIST 1: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir
Related Studies:
Other HIV Infections Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients
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