A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA
1 other identifier
observational
70
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
8 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
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 2000
November 2, 1999
June 23, 2005
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Univ of Washington
Seattle, Washington, 981224304, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Para MF
- STUDY CHAIR
Demeter L
Study Design
- Study Type
- observational
- Observational Model
- NATURAL HISTORY
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 2000-04