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NCT00001137 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00001137
Other study ID # ACTG A5001
Secondary ID 1U01AI068636AACT
Status Completed
Phase N/A
First received January 28, 2000
Last updated December 5, 2013
Start date January 2000
Est. completion date November 2013

Study information
Verified date December 2013
Source AIDS Clinical Trials Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 5982
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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, including the visit window 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Puerto Rico Univ of Puerto Rico San Juan
Puerto Rico Puerto Rico-AIDS CRS San Juan,
United States Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr Atlanta Georgia
United States Emory Univ Atlanta Georgia
United States IHV Baltimore Treatment CRS Baltimore Maryland
United States Johns Hopkins Hosp Baltimore Maryland
United States Univ of Alabama at Birmingham Birmingham Alabama
United States Beth Israel Deaconess - West Campus Boston Massachusetts
United States Boston Med Ctr Boston Massachusetts
United States Brigham and Women's Hosp Boston Massachusetts
United States Harvard (Massachusetts Gen Hosp) Boston Massachusetts
United States Bronx-Lebanon Hosp. Ctr. CRS Bronx New York
United States SUNY / Erie County Med Ctr at Buffalo Buffalo New York
United States Cooper Univ. Hosp. CRS Camden New Jersey
United States Univ of North Carolina Chapel Hill North Carolina
United States Wake County Department of Health Chapel Hill North Carolina
United States Carolinas Med Ctr Charlotte North Carolina
United States Cook County Hosp Chicago Illinois
United States Northwestern Univ Med School Chicago Illinois
United States Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois
United States Univ of Cincinnati Cincinnati Ohio
United States Cleveland Clinic Cleveland Ohio
United States MetroHealth Med Ctr Cleveland Ohio
United States Ohio State Univ Hosp Clinic Columbus Ohio
United States Peabody Health Center CRS Dallas Texas
United States Univ of Texas, Southwestern Med Ctr of Dallas Dallas Texas
United States Denver Public Health CRS Denver Colorado
United States Univ of Colorado Health Sciences Ctr Denver Colorado
United States Wayne State Univ. CRS Detroit Michigan
United States Duke Univ Med Ctr Durham North Carolina
United States Moses H Cone Memorial Hosp Greensboro North Carolina
United States Univ of Hawaii Honolulu Hawaii
United States Houston AIDS Research Team CRS Houston Texas
United States Division of Inf Diseases/ Indiana Univ Hosp Indianapolis Indiana
United States Indiana Univ Hosp Indianapolis Indiana
United States Methodist Hosp of Indiana / Life Care Clinic Indianapolis Indiana
United States Univ of Iowa Hosp and Clinic Iowa City Iowa
United States Kaiser Permanente LAMC Los Angeles California
United States UCLA CARE Ctr Los Angeles California
United States Univ of Southern California / LA County USC Med Ctr Los Angeles California
United States Willow Clinic Menlo Park California
United States Univ of Miami School of Medicine Miami Florida
United States Hennepin County Medical Clinic Minneapolis Minnesota
United States Univ of Minnesota Minneapolis Minnesota
United States Vanderbilt Univ Med Ctr Nashville Tennessee
United States Tulane Med Ctr Hosp New Orleans Louisiana
United States Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ New York New York
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Beth Israel Med Ctr New York New York
United States Chelsea Ctr New York New York
United States Columbia Presbyterian Med Ctr New York New York
United States Cornell Univ Med Ctr New York New York
United States Mount Sinai Med Ctr New York New York
United States NY Univ. HIV/AIDS CRS New York New York
United States New Jersey Medical School- Adult Clinical Research Ctr. CRS Newark New Jersey
United States Presbyterian Medical Center - Univ. of PA Norristown Pennsylvania
United States Univ of Nebraska Med Ctr Omaha Nebraska
United States Univ of Pennsylvania at Philadelphia Philadelphia Pennsylvania
United States Univ of Pittsburgh Pittsburgh Pennsylvania
United States The Research & Education Group-Portland CRS Portland Oregon
United States Virginia Commonwealth Univ. Medical Ctr. CRS Richmond Virginia
United States Community Health Network Inc Rochester New York
United States Univ of Rochester Medical Center Rochester New York
United States AIDS Care CRS Rochester, New York
United States UC Davis Med Ctr Sacramento California
United States Univ of California / San Diego Treatment Ctr San Diego California
United States Univ of California, San Francisco/San Francisco General Hosp San Francisco California
United States Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium San Jose California
United States Marin County Specialty Clinic San Rafael California
United States Univ of Washington Seattle Washington
United States St Louis Regional Hosp / St Louis Regional Med Ctr St Louis Missouri
United States San Mateo AIDS Program / Stanford Univ Stanford California
United States Stanford Univ Med Ctr Stanford California
United States Harbor UCLA Med Ctr Torrance California
United States Tripler Army Med Ctr Tripler AMC Hawaii
United States Georgetown Univ Med Ctr Washington District of Columbia
United States Julio Arroyo West Columbia South Carolina

Sponsors (2)
Lead Sponsor Collaborator
AIDS Clinical Trials Group National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (2)

Jain R, Clark NM, Diaz-Linares M, Grim SA. Limitations of current antiretroviral agents and opportunities for development. Curr Pharm Des. 2006;12(9):1065-74. Review. — View Citation

Torre D, Speranza F, Martegani R. Impact of highly active antiretroviral therapy on organ-specific manifestations of HIV-1 infection. HIV Med. 2005 Mar;6(2):66-78. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Successive suppressed viral load measures Measured 144 weeks after randomization Yes
Primary Genotypic or phenotypic resistance Measured at baseline and study completion No
Primary Complications of HIV disease, including survival, HIV-related opportunistic infections, HIV-related non-opportunistic complications, adverse effects of antiretroviral therapies of grade three or greater Measured throughout Yes
Primary Absolute number and percentage of CD4 and CD8 T cells Measured 144 weeks after randomization No
Primary Absolute number and percentage of naive cells, including CD4, CD45RA, and CD62L cells Measured 144 weeks after randomization No
Primary Absolute number and percentage of memory cells, including CD4, CD45RO+, and CD45RA- cells Measured 144 weeks after randomization No
Primary Levels of immune activation markers, including CD8, CD38, and HLA-DR cells Measured 144 weeks after randomization No
Secondary HIV-1 latency or replication in tissue or cellular reservoirs Measured at baseline, Week 16, Week 48, and study completion No
Secondary Syncytium and non-syncytium inducing (SI/NSI) phenotype Measured at baseline, Week 16, Week 48, and study completion No
Secondary Metabolic and neurologic complications Measured at baseline, Week 16, Week 48, and study completion Yes
Secondary Immune responses to antigens such as cytomegalovirus (CMV), Myobacterium avium complex (MAC), Candida, and HIV Measured 144 weeks after randomization No
Secondary Plasma concentrations of antiretroviral medications other than nucleoside/tide reverse transcriptase inhibitors (NRTIs) Measured at baseline, Week 16, and study completion No
Secondary Effect of gender, use of hormonal therapies, presence or absence of menopause on short- and long-term virologic suppression, and pap smear abnormalities Measured at baseline, Week 48, and study completion Yes
Secondary Quality of life scores Measured at baseline, Week 48, and study completion No
Secondary Subject-reported patterns of adherence Measured at baseline, Week 48, and study completion No
Secondary Estimated inpatient, outpatient, and total costs Measured at study completion No
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