Completed

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

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What is being collected

Data Collection

Who is being recruted

HIV Infections

Over 13 Years
How is the trial designed

Natural History

Observing the progression of a disease in untreated individuals in order to understand its typical course and outcomes.
Observational

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitleA Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
70 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Natural History
These studies observe how a disease progresses over time without active treatment. They help researchers understand how conditions typically develop, change, and impact quality of life.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Criteria
No eligibility criteria are available at this time.Please check with the study contact for more details. 
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 8 locations
Suspended
Northwestern Univ Med SchoolChicago, United StatesSee the location
Suspended
Rush Presbyterian - Saint Luke's Med CtrChicago, United States
Suspended
Johns Hopkins HospBaltimore, United States
Suspended
SUNY / Erie County Med Ctr at BuffaloBuffalo, United States

Completed8 Study Centers
A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA | PatLynk