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

Tracking Information

First Received Date ^ICMJE

January 28, 2000

Last Updated Date

November 5, 2009

Start Date ^ICMJE

January 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00001137 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

4500

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Location Countries ^ICMJE

United States, Puerto Rico

Administrative Information

NCT ID ^ICMJE

NCT00001137

Responsible Party

Rona Siskind, DAIDS

Study ID Numbers ^ICMJE

ACTG A5001, AACTG A5001

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Investigators ^ICMJE

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

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP