Long-Term Data Collection From Participants in Adult AIDS Clinical Trials - Tabular View

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Long-Term Data Collection From Participants in Adult AIDS Clinical Trials

This study is currently recruiting participants.

Study NCT00001137. Last updated on September 24, 2008. Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Long-Term Data Collection From Participants in Adult AIDS Clinical Trials

Official Title ^†

Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol

Brief Summary

The purpose of this study is to determine what combinations of anti-HIV drugs work best in patients treated over several years. The study will also assess the occurrence of side effects and opportunistic infections in patients with low viral loads compared to those with higher viral loads.

Detailed Description

A compilation of outcomes of various antiretroviral therapies would be beneficial when evaluating which strategies are most effective in long-term treatment of HIV-1. Using data from present and recently completed studies, this study will collect information on therapies and their control of HIV infection and maintenance of durable suppression of HIV-1 replication.

No treatment is provided by this study, but patients will continue to receive highly active antiretroviral therapy (HAART) from other studies in which they are coenrolled. Blood and urine collection will occur at study entry and periodically throughout the study. Women may undergo pelvic exams and Pap smears. Portions of blood samples will be stored to evaluate genotypic/phenotypic susceptibility testing. Medical histories, physical exams, and questionnaires will be completed periodically.

Study Phase

Study Type ^†

Observational

Study Design ^†

Cohort, Prospective

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

HIV Infections

Intervention ^†

MEDLINE PMIDs

16515486, 15807712

Links

Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

4500

Start Date ^†

January 2000

Completion Date

Eligibility Criteria ^†

Inclusion Criteria

HIV-1 infected
Enrolled in an AIDS Clinical Trial Group (ACTG) parent study and has enrolled in this study on or before the Week 16 visit of the parent study. More information on this criterion can be found in the protocol.
Willing to provide consent for the release and use of clinical data from the parent study
Life expectancy of at least 24 weeks
Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria

Active alcohol or drug abuse that may interfere with the study

Gender

Both

Ages

13 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Puerto Rico

Administrative Information Fields

NCT ID ^†

NCT00001137

Organization ID

ACTG A5001

Secondary IDs ^††

AACTG A5001

Study Sponsor ^†

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^††

Investigators ^†

Study Chair:	Constance A. Benson, MD	Division of Infectious Disease, Antiviral Research Center, University of California, San Diego
Study Chair:	Ann C. Collier, MD	University of Washington, Harborview Medical Center

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

March 2006

First Received Date ^†

January 28, 2000

Last Updated Date

September 24, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.