Completed
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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-28
1900
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 14 locations
1
Community Consortium of San Francisco
San Francisco, California, United States, 94110
Status Unknown
2
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 802044507
Status Unknown
3
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, United States, 20422
Status Unknown
4
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Status Unknown
5
AIDS Research Alliance - Chicago
Chicago, Illinois, United States, 60657
Status Unknown
6
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States, 70112
Status Unknown
7
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States, 48201
Status Unknown
8
Henry Ford Hosp
Detroit, Michigan, United States, 48202
Status Unknown
9
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, United States, 08103
Status Unknown
10
North Jersey Community Research Initiative
Newark, New Jersey, United States, 071032842
Status Unknown
11
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States, 10037
Status Unknown
12
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 972109951
Status Unknown
13
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
Status Unknown
14
Richmond AIDS Consortium
Richmond, Virginia, United States, 23298
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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