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

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000840

Purpose

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.

Condition
HIV Infections

Study Type:	Observational
Study Design:	Natural History
Official Title:	A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

70

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.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000840

Locations

United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
United States, New York
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
United States, Ohio
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
United States, Washington
Univ of Washington
Seattle, Washington, United States, 981224304

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:	Para MF
Study Chair:	Demeter L

More Information

No publications provided

Study ID Numbers:	ACTG 304
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000840 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Zidovudine

Biological Markers
Viremia
RNA, Viral

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 27, 2009