A Study of HIV-Disease Development in Aging
A Phase II Exploratory Study Examining Immunologic and Virologic Indices in Two Age-Differentiated Cohorts of HIV-Infected Subjects to Explore the Basis of Accelerated HIV-Disease Progression Associated With Aging
6 other identifiers
interventional
90
2 countries
45
Brief Summary
The purpose of this study is to better understand the relationship between age and HIV disease progression. This study will explore the possible relationship between age and HIV disease progression. Older age is an important risk factor for faster disease development, but older people may respond better to combination drug therapy. This relationship needs to be understood better.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
Started Oct 2000
Typical duration for phase_2 hiv-infections
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2000
CompletedStudy Start
First participant enrolled
October 1, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedNovember 1, 2021
October 1, 2021
August 7, 2000
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Are between 13 and 30 years old (need consent of parent or guardian if under 18), or are more than 44 years of age.
- Have a viral load of more than 2000 copies/ml within 60 days of study entry.
- Have a CD4 cell count of less than 600 cells/mm3 within 60 days of study entry. (This reflects a change in the CD4 cell count requirement.)
- Agree to use effective methods of birth control (such as condoms) during and for 12 weeks after the study.
You may not qualify if:
- Patients will not be eligible for this study if they:
- Are pregnant or breast-feeding.
- Have an AIDS-related cancer (except Kaposi's sarcoma) requiring chemotherapy.
- Have hepatitis within 30 days of study entry.
- Have diarrhea (more than 3 liquid stools/day for at least 14 days) within 30 days of study entry.
- Are receiving chemotherapy or radiation treatment.
- Have taken antiretroviral drugs for more than 14 days.
- Have received an HIV vaccine within 30 days of study.
- Have a serious illness or infection within 14 days of the study.
- Have other serious conditions that might interfere with study participation.
- Have taken or plan to take certain other drugs that might affect the study results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
USC CRS
Los Angeles, California, 900331079, United States
Stanford CRS
Palo Alto, California, 943055107, United States
Ucsf Aids Crs
San Francisco, California, 941102859, United States
Santa Clara Valley Med. Ctr.
San Jose, California, 951282699, United States
San Mateo County AIDS Program
San Mateo, California, 943055107, United States
Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic
San Rafael, California, 94903, United States
University of Colorado Hospital CRS
Aurora, Colorado, 80262, United States
Univ. of Miami AIDS CRS
Miami, Florida, 331361013, United States
Queens Med. Ctr.
Honolulu, Hawaii, 96816, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 462025250, United States
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, 46202, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, 46202, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114, United States
Bmc Actg Crs
Boston, Massachusetts, 02118, United States
Brigham and Women's Hosp. ACTG CRS
Boston, Massachusetts, 02215, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States
SSTAR, Family Healthcare Ctr.
Fall River, Massachusetts, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455, United States
Washington U CRS
St Louis, Missouri, United States
Beth Israel Med. Ctr., ACTU
New York, New York, 10003, United States
NY Univ. HIV/AIDS CRS
New York, New York, 10016, United States
Mt. Sinai Med. Ctr. A0404 CRS
New York, New York, 10029, United States
Columbia Univ., HIV Prevention and Treatment Medical Ctr.
New York, New York, United States
Mt.Sinai Med. Ctr. A1009 CRS
New York, New York, United States
Trillium Health ACTG CRS
Rochester, New York, 14607, United States
AIDS Care CRS
Rochester, New York, 14642, United States
Univ. of Rochester ACTG CRS
Rochester, New York, 14642, United States
Unc Aids Crs
Chapel Hill, North Carolina, 275997215, United States
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, 27710, United States
Case CRS
Cleveland, Ohio, 44106, United States
MetroHealth CRS
Cleveland, Ohio, 441091998, United States
The Ohio State University Medical Center
Columbus, Ohio, 432101228, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104, United States
Philadelphia Veterans Admin. Med. Ctr. A6205 CRS
Philadelphia, Pennsylvania, 19104, United States
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, 02906, United States
Rhode Island Hosp.
Providence, Rhode Island, United States
Vanderbilt Therapeutics CRS
Nashville, Tennessee, United States
Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
Dallas, Texas, 75235-9173, United States
Univ. of Texas Medical Branch, ACTU
Galveston, Texas, 77555-0435, United States
University of Washington AIDS CRS
Seattle, Washington, 98104, United States
Puerto Rico-AIDS CRS
San Juan, 009365067, Puerto Rico
Related Publications (2)
Kalayjian R, Landay A, Pollard R, Pu M, Spritzer J, Tebas P, Gross B, Valcour V, Cu-Uvin S, Fiscus S, Fidel P, Wu A, Fox L, Stocker V, Lederman M, and AIDS Clinical Trials Group Protocol 5015. ACTG 5015: NaIve T-cell Reconstitution is Associated with Immune Activation. CROI 2004. Abstract 232.
BACKGROUNDTenorio AR, Spritzler J, Martinson J, Gichinga CN, Pollard RB, Lederman MM, Kalayjian RC, Landay AL. The effect of aging on T-regulatory cell frequency in HIV infection. Clin Immunol. 2009 Mar;130(3):298-303. doi: 10.1016/j.clim.2008.10.001. Epub 2008 Nov 12.
PMID: 19008157DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert Kalayjian
- STUDY CHAIR
Michael Lederman
- STUDY CHAIR
Richard Pollard
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2000
First Posted
August 31, 2001
Study Start
October 1, 2000
Study Completion
April 1, 2005
Last Updated
November 1, 2021
Record last verified: 2021-10