A Study of the Long-Term Outcomes of HIV-Positive Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00000932
- Brief Summary
The purpose of this study is to collect information about life spans and HIV-related illnesses in multiple groups of HIV-positive patients with varying anti-HIV treatment experience, including no treatment at all.
Anti-HIV treatment has been successful in slowing disease progression in many patients. However, there are still questions regarding the best way to use anti-HIV drugs. This study is designed to provide long-term monitoring of patients who have already received anti-HIV treatment as well as patients who are just beginning treatment or have decided not to receive treatment.
- Detailed Description
Highly active antiretroviral therapy (HAART) often results in short-term benefits for people with HIV in terms of reduced plasma viral levels and increased CD4 cell counts. When used at an early stage of HIV disease, however, the clinical benefit of HAART is uncertain. Many questions still remain regarding the optimal use of antiretroviral therapies, such as the timing of initial antiretroviral therapy and the composition of the best combination regimen to use initially or after virologic failure. Randomized trials of different starting antiretroviral regimens (e.g., FIRST \[CPCRA 058\]), different regimens after initial virologic failure (e.g., PIP \[CPCRA 057\]), and different management strategies for HIV infection (e.g., bis-POM \[CPCRA 039\], NvR \[CPCRA 042\], GART \[CPCRA 046\], and IL-2 VL/Dose \[CPCRA 059\] are being conducted by the CPCRA. \[AS PER AMENDMENT 2/28/01: The MDR-HIV (CPCRA 064) protocol is now included as an example of a different management strategy for HIV infection, whereas the bis-POM (CPCRA 039) protocol is no longer included.\] This study provides a mechanism for long-term monitoring of patients enrolled in these trials as well as antiretroviral-naive patients who are either starting treatment or electing to defer treatment.
Patients are divided into 3 groups. Group A consists of patients currently enrolled in or currently being followed in an ongoing qualifying study (see Purpose for CPCRA trials which qualify). Group B consists of patients previously enrolled in but not currently being followed in a qualifying study. Group C consists of antiretroviral-naive patients not enrolling in a qualifying study (i.e., patients starting treatment outside the FIRST study or patients deferring treatment). Patients in Group A undergo monitoring of selected clinical and laboratory parameters (including plasma HIV RNA levels and CD4 cell counts) once every 4 weeks beginning after completion of all follow-up appointments for all other protocols in which they were enrolled. Patients in Groups B and C undergo monitoring of selected clinical and laboratory parameters (including plasma HIV RNA levels and CD4 cell counts) once every 4 months. Patients are followed for at least 5 years. \[AS PER AMENDMENT 2/28/01: Patients who are not being followed in a qualifying protocol and are antiretroviral naive at enrollment or were previously enrolled in the FIRST (CPCRA 058) protocol undergo blood draws at enrollment and then annually for measurement of plasma HIV levels by a CPCRA-approved laboratory and future CPCRA-approved, HIV-related research. Patients who relocate to a non-CPCRA affiliated site are asked to sign a consent for ongoing release (every 4 months) of their medical records from their new health care provider to the CPCRA.\]
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3669
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical disease progression or death Throughout study
- Secondary Outcome Measures
Name Time Method Survival Throughout study Selected metabolic, hepatic, and cardiovascular conditions Throughout study Changes in viral load Throughout study Changes in CD4 count Throughout study Changes in HIV treatment methods Throughout study
Trial Locations
- Locations (91)
Dr. Virginia Cafaro Med. Practice CRS
🇺🇸San Francisco, California, United States
UCSF PHP, Gen. Internal Medicine Practice CRS
🇺🇸San Francisco, California, United States
Cook County Hosp. CORE Ctr. INSIGHT CRS
🇺🇸Chicago, Illinois, United States
Cook County Hosp. CORE Ctr.
🇺🇸Chicago, Illinois, United States
Univ. of Illinois Family Ctr. for Infectious Disease CRS
🇺🇸Chicago, Illinois, United States
North Side Family Medicine CRS
🇺🇸Chicago, Illinois, United States
Northwestern Memorial Physicians Group CRS
🇺🇸Chicago, Illinois, United States
Legacy Community Health Services, Inc. CRS
🇺🇸Houston, Texas, United States
Baylor College of Medicine, Thomas St. Clinic CRS
🇺🇸Houston, Texas, United States
Houston AIDS Research Team CRS
🇺🇸Houston, Texas, United States
Michael E. DeBakey VAMC CRS
🇺🇸Houston, Texas, United States
Castro-Mission Health Ctr. CRS
🇺🇸San Francisco, California, United States
San Francisco VAMC, Infectious Diseases Clinic CRS
🇺🇸San Francisco, California, United States
Dotson & Hodge Med. Group, L.L.C. CRS
🇺🇸Washington, District of Columbia, United States
Jersey Shore Univ. Med. Ctr. CRS
🇺🇸Neptune, New Jersey, United States
Univ. of Connecticut Health Ctr. CRS
🇺🇸Farmington, Connecticut, United States
St. Mary's Med. Ctr. of San Francisco CRS
🇺🇸San Francisco, California, United States
CRI-Springfield CRS
🇺🇸Springfield, Massachusetts, United States
Dr. Shawn Hassler Med. Practice CRS
🇺🇸San Francisco, California, United States
Dr. William Owen Med. Practice CRS
🇺🇸San Francisco, California, United States
Dr. M. Estes Med. Practice CRS
🇺🇸Mill Valley, California, United States
Hanover Med. Park (Mechanicsville, VA) CRS
🇺🇸Mechanicsville, Virginia, United States
Thomas Street Clinic CRS
🇺🇸Houston, Texas, United States
Eastern Virginia Med. School, Ctr. for the Comprehensive Care of Immune Deficiency CRS
🇺🇸Norfolk, Virginia, United States
HHC Methadone Maintenance, Treatment Program Unit 1 CRS
🇺🇸New York, New York, United States
James Osterberger, MD (Private Med. Practice) CRS
🇺🇸Baton Rouge, Louisiana, United States
Petersburg Health Care Alliance CRS
🇺🇸Petersburg, Virginia, United States
Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS
🇺🇸San Francisco, California, United States
East Bay AIDS Ctr. CRS
🇺🇸Oakland, California, United States
Dr. Martin Mass Med. Practice CRS
🇺🇸San Francisco, California, United States
Beacon Clinic at Boulder CRS
🇺🇸Boulder, Colorado, United States
Western Infectious Disease Consultants CRS
🇺🇸Wheat Ridge, Colorado, United States
Klein & Slotten Medical Associates CRS
🇺🇸Chicago, Illinois, United States
Dr. Timothy A. Price Med. Practice CRS
🇺🇸Washington, District of Columbia, United States
Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
🇺🇸Washington, District of Columbia, United States
Lakeshore Infectious Disease Associates CRS
🇺🇸Chicago, Illinois, United States
Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS
🇺🇸Baton Rouge, Louisiana, United States
CRI-Boston CRS
🇺🇸Boston, Massachusetts, United States
Cathedral Healthcare System, St. Michael's Med. Ctr. CRS
🇺🇸Newark, New Jersey, United States
Cooper Univ. Hosp. CRS
🇺🇸Camden, New Jersey, United States
New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS
🇺🇸Newark, New Jersey, United States
St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS
🇺🇸Paterson, New Jersey, United States
Raritan Bay Med. Ctr., Perth Amboy Division CRS
🇺🇸Perth Amboy, New Jersey, United States
ID Care - Randolph CRS
🇺🇸Randolph, New Jersey, United States
The Early Intervention Program at Kennedy Hosp. CRS
🇺🇸Voorhees, New Jersey, United States
Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS
🇺🇸Union, New Jersey, United States
Jacobi Med. Ctr., Ambulatory Care Pavillion CRS
🇺🇸Bronx, New York, United States
Bronx Prevention Center CRS
🇺🇸Bronx, New York, United States
Montefiore Med. Ctr., AIDS Ctr. CRS
🇺🇸Bronx, New York, United States
Jacobi Med. Ctr.
🇺🇸Bronx, New York, United States
St. Vincent Hosp. & Med. Ctr. CRS
🇺🇸New York, New York, United States
Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)
🇺🇸New York, New York, United States
Salem Hosp. CRS
🇺🇸Salem, Oregon, United States
Philadelphia FIGHT - Dr. Jay Kostman CRS
🇺🇸Philadelphia, Pennsylvania, United States
Temple Univ. School of Medicine CRS
🇺🇸Philadelphia, Pennsylvania, United States
Kaiser Permanente Lancaster Clinic CRS
🇺🇸Salem, Oregon, United States
Bronx-Lebanon Hosp. Ctr. CRS
🇺🇸Bronx, New York, United States
Dr. Robert Scott Med. Practice CRS
🇺🇸Oakland, California, United States
APEX Family Medicine CRS
🇺🇸Denver, Colorado, United States
Triad Health Practice/Ill. Masonic Med. Ctr. CRS
🇺🇸Chicago, Illinois, United States
ID Care Inc. - Hillsborough CRS
🇺🇸Hillsborough, New Jersey, United States
Yale Univ. School of Medicine, NE ProACT - New Haven CRS
🇺🇸New Haven, Connecticut, United States
Denver Infectious Diseases Consultants CRS
🇺🇸Denver, Colorado, United States
Kaiser Permanente of Denver CRS
🇺🇸Denver, Colorado, United States
Univ. of Colorado Health Science Ctr. CRS
🇺🇸Denver, Colorado, United States
Denver Public Health CRS
🇺🇸Denver, Colorado, United States
Eastside Family Health Ctr. CRS
🇺🇸Denver, Colorado, United States
South Denver Infectious Diseases Specialists, Accord Med. Ctr. CRS
🇺🇸Denver, Colorado, United States
Denver Public Health CRS - INSIGHT
🇺🇸Denver, Colorado, United States
Detroit Community Health Connection-2 CRS
🇺🇸Detroit, Michigan, United States
Hosp. of St. Raphael CRS
🇺🇸New Haven, Connecticut, United States
Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS
🇺🇸New Orleans, Louisiana, United States
New Orleans VAMC CRS
🇺🇸New Orleans, Louisiana, United States
Harper Hosp., Detroit CRS
🇺🇸Detroit, Michigan, United States
Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS
🇺🇸New Orleans, Louisiana, United States
Memorial Med. Ctr., Hematology-Oncology Services CRS
🇺🇸New Orleans, Louisiana, United States
Wayne State Univ. INSIGHT CRS
🇺🇸Detroit, Michigan, United States
Detroit Community Health Connection, Inc. CRS
🇺🇸Detroit, Michigan, United States
Henry Ford Hosp. CRS
🇺🇸Detroit, Michigan, United States
The Research & Education Group-Portland CRS
🇺🇸Portland, Oregon, United States
Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS
🇺🇸Portland, Oregon, United States
Kaiser Immune Deficiency Clinic of Portland CRS
🇺🇸Portland, Oregon, United States
Legacy Clinic Emanuel CRS
🇺🇸Portland, Oregon, United States
Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
🇺🇸Portland, Oregon, United States
Multnomah County Health Dept., HIV Health Services Ctr. CRS
🇺🇸Portland, Oregon, United States
Legacy Clinic Good Samaritan CRS
🇺🇸Portland, Oregon, United States
CrossOver Health Ctr. CRS
🇺🇸Richmond, Virginia, United States
Hunter Holmes McGuire VAMC CRS
🇺🇸Richmond, Virginia, United States
South Richmond Health Care Ctr. CRS
🇺🇸Richmond, Virginia, United States
VCU Health Systems, Infectious Disease Clinic CRS
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth Univ. Medical Ctr. CRS
🇺🇸Richmond, Virginia, United States