Completed
A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2005-06-24
70
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate viral load in the blood stream of HIV-infected patients during a 28-day washout following cessation of long-term zidovudine ( AZT ) therapy. Because viral load (amount of HIV RNA in the plasma) is often used as a measure of the effectiveness of new antiretroviral drugs in clinical trials, a washout period, or cessation of current antiretroviral regimens, is commonly required for study entry to allow for a drug-free steady state of viral load prior to initiation of the new drug. However, the kinetics of the viral rebound following drug withdrawal has not been sufficiently studied, and the proper duration of washout is an estimate.
CONDITIONS
Official Title
A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Concurrent Medication:
Allowed:
- Maintenance therapy for opportunistic infection, provided patient has received at least 1 month of stable therapy prior to study.
- G-CSF.
Patients must have:
- HIV infection.
- CD4 count <= 500 cells/mm3.
- At least 12 months of prior AZT, with 2 months of continuous AZT monotherapy immediately prior to study.
- The need to discontinue AZT because of drug-related toxicity or unwanted side effects or as an entry requirement for another research study.
- Consent of parent or guardian if < 18 years old.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Current medical status that is considered unsuitable for study participation.
Concurrent Medication:
Excluded:
- Therapy for an acute opportunistic infection.
Prior Medication:
Excluded within the past 2 months:
- Antiretrovirals other than AZT.
- Systemic immunomodulators (e.g., gp120, gp160, IL-2, and interferons).
Excluded within the past month:
- Vaccination.
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: 8 locations
1
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Status Unknown
2
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Status Unknown
3
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Status Unknown
4
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Status Unknown
5
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Status Unknown
6
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Status Unknown
7
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
Status Unknown
8
Univ of Washington
Seattle, Washington, United States, 981224304
Status Unknown
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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