A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA

Completed

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000840

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

70

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Northwestern Univ Med School — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• SUNY / Erie County Med Ctr at Buffalo — Buffalo, New York, United States
• Univ of Rochester Medical Center — Rochester, New York, United States
• Case Western Reserve Univ — Cleveland, Ohio, United States
• Ohio State Univ Hosp Clinic — Columbus, Ohio, United States
• Univ of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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