Status:
COMPLETED
A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
13+ years
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 p...
Detailed Description
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 antiretro...
Eligibility Criteria
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.
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00000840
Last Update
June 24 2005
Active Locations (8)
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1
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
2
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
3
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
4
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215