The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
First received: November 2, 1999
Last updated: May 1, 2012
Last Verified: May 2012
History of Changes
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.
Drug : Indinavir sulfate
Primary Purpose: Treatment
|Official Title:||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|
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
|Study Completion Date:||March 1997|
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
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.
|Ages Eligible for Study:||16 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
- The DAIDS Clinical Science Research Committee (CSRC) has deemed this protocol appropriate for prisoner enrollment.
- Non-nucleoside reverse transcriptase inhibitors.
- Protease inhibitors except IDV.
- Rifabutin and rifampin.
- Terfenadine, astemizole, cisapride, triazolam and midazolam.
- 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.
Patients must have:
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.
Patients with any of the following prior conditions are excluded:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000861
Locations Show More
|United States, California|
|Community Consortium of San Francisco|
|San Francisco, California, United States, 94110|
|United States, Colorado|
|Denver CPCRA / Denver Public Hlth|
|Denver, Colorado, United States, 802044507|
|United States, District of Columbia|
|Veterans Administration Med Ctr / Regional AIDS Program|
|Washington, District of Columbia, United States, 20422|
|United States, Georgia|
|AIDS Research Consortium of Atlanta|
|Atlanta, Georgia, United States, 30308|
|United States, Illinois|
|AIDS Research Alliance - Chicago|
|Chicago, Illinois, United States, 60657|
|United States, Louisiana|
|Louisiana Comm AIDS Rsch Prog / Tulane Univ Med|
|New Orleans, Louisiana, United States, 70112|
|United States, Michigan|
|Comprehensive AIDS Alliance of Detroit|
|Detroit, Michigan, United States, 48201|
|Henry Ford Hosp|
|Detroit, Michigan, United States, 48202|
|United States, New Jersey|
|Southern New Jersey AIDS Cln Trials / Dept of Med|
|Camden, New Jersey, United States, 08103|
|North Jersey Community Research Initiative|
|Newark, New Jersey, United States, 071032842|
|United States, New York|
|Harlem AIDS Treatment Group / Harlem Hosp Ctr|
|New York, New York, United States, 10037|
|United States, Oregon|
|Portland Veterans Adm Med Ctr / Rsch & Education Grp|
|Portland, Oregon, United States, 972109951|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Virginia|
|Richmond AIDS Consortium|
|Richmond, Virginia, United States, 23298|
Sponsors and CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)
|Study Chair:||Saravolatz L|
|Study Chair:||Crane L|
|Study Chair:||Mayers D|
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|ClinicalTrials.gov Identifier:||NCT00000861 History of Changes|
|Other Study ID Numbers:||CPCRA 041|
|Study First Received:||November 2, 1999|
|Last Updated:||May 1, 2012|
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):Drug Administration Schedule
HIV Protease Inhibitors
CD4 Lymphocyte Count
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.