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

NCT ID: NCT00000840

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL

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.

Conditions

HIV Infections

Study Design

• Observational Model Type: NATURAL_HISTORY

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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Principal Investigators

Para MF

Role: STUDY_CHAIR

Demeter L

Role: STUDY_CHAIR

Locations

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

Countries

United States

Other Identifiers

ACTG 304

Identifier Type: -

Identifier Source: org_study_id