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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000840
• Other study ID #: ACTG 304
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 2000
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Observational Model: Natural History

Related Conditions & MeSH terms

• HIV Infections

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,