A Study of HIV-Disease Development in Aging
- Conditions
- HIV Infections
- Registration Number
- NCT00006144
- 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.
- Detailed Description
Older age is an important risk factor for accelerated HIV-disease progression. However, the virologic response to highly active antiretroviral therapy (HAART) may be superior in older persons. A better understanding of the immunologic, virologic, and behavioral mechanisms that underlie these age-related differences may help to elucidate critical immune responses that are necessary to control the progression of HIV-disease.
Patients are grouped according to age. Group A consists of patients between the ages of 13 and 30 years. Group B consists of patients age 45 years or older. All patients receive open-label lopinavir/ritonavir (LPV/RTV) plus emtricitabine (FTC) plus stavudine (d4T) for 96 \[AS PER AMENDMENT 06/04/02: 192\] weeks. Study visits occur at pre-entry, entry, and Weeks 4, 8, 12, 16, and 24 then every 12 weeks thereafter through Week 96 \[AS PER AMENDMENT 06/04/02: Week 192\]. Clinical assessments, safety laboratory tests, CD4 cell count monitoring, lymphocyte phenotyping, and HIV-1 RNA determinations are performed routinely. Blood samples are stored for further immunology and virology studies. Patients may volunteer to participate in virology substudy A5020s and either immunology substudy A5016s or A5017s \[AS PER AMENDMENT 06/04/02: Substudy A5017s has been eliminated.\]
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (45)
Santa Clara Valley Med. Ctr.
🇺🇸San Jose, California, United States
Mt. Sinai Med. Ctr. A0404 CRS
🇺🇸New York, New York, 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
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
The Miriam Hosp. ACTG CRS
🇺🇸Providence, Rhode Island, United States
Rhode Island Hosp.
🇺🇸Providence, Rhode Island, United States
Puerto Rico-AIDS CRS
🇵🇷San Juan, Puerto Rico
Stanford CRS
🇺🇸Palo Alto, California, United States
San Mateo County AIDS Program
🇺🇸San Mateo, California, United States
Beth Israel Med. Ctr., ACTU
🇺🇸New York, New York, United States
Washington U CRS
🇺🇸Saint Louis, Missouri, United States
Trillium Health ACTG CRS
🇺🇸Rochester, New York, United States
NY Univ. HIV/AIDS CRS
🇺🇸New York, New York, United States
AIDS Care CRS
🇺🇸Rochester, New York, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Univ. of Miami AIDS CRS
🇺🇸Miami, Florida, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States
Rush Univ. Med. Ctr. ACTG CRS
🇺🇸Chicago, Illinois, United States
Methodist Hosp. of Indiana
🇺🇸Indianapolis, Indiana, United States
Bmc Actg Crs
🇺🇸Boston, Massachusetts, United States
Unc Aids Crs
🇺🇸Chapel Hill, North Carolina, United States
Duke Univ. Med. Ctr. Adult CRS
🇺🇸Durham, North Carolina, United States
Case CRS
🇺🇸Cleveland, Ohio, United States
USC CRS
🇺🇸Los Angeles, California, United States
Ucsf Aids Crs
🇺🇸San Francisco, California, United States
Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic
🇺🇸San Rafael, California, United States
Queens Med. Ctr.
🇺🇸Honolulu, Hawaii, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Indiana Univ. School of Medicine, Wishard Memorial
🇺🇸Indianapolis, Indiana, United States
Johns Hopkins Adult AIDS CRS
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital ACTG CRS
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hosp. ACTG CRS
🇺🇸Boston, Massachusetts, 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, United States
MetroHealth CRS
🇺🇸Cleveland, Ohio, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
🇺🇸Philadelphia, Pennsylvania, United States
Philadelphia Veterans Admin. Med. Ctr. A6205 CRS
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt Therapeutics CRS
🇺🇸Nashville, Tennessee, United States
Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
🇺🇸Dallas, Texas, United States
Univ. of Texas Medical Branch, ACTU
🇺🇸Galveston, Texas, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States