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

Completed

• Conditions: HIV Infections

• Registration Number: NCT00000840
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

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 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.

Patients who have volunteered to temporarily cease antiretroviral therapy will be followed during a 28-day washout period. Blood samples are drawn at each of nine clinic visits. Patients may resume antiretrovirals after the 28-day washout.

Study Timeline

• Study First Submitted: 1999-11-02
• Status Verified: 2000-04
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (8)

Northwestern Univ Med School; 🇺🇸 Chicago, Illinois, United States

Rush Presbyterian - Saint Luke's Med Ctr; 🇺🇸 Chicago, Illinois, United States

Ohio State Univ Hosp Clinic; 🇺🇸 Columbus, Ohio, United States

SUNY / Erie County Med Ctr at Buffalo; 🇺🇸 Buffalo, New York, United States

Johns Hopkins Hosp; 🇺🇸 Baltimore, Maryland, United States

Univ of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Case Western Reserve Univ; 🇺🇸 Cleveland, Ohio, United States

Univ of Washington; 🇺🇸 Seattle, Washington, United States