A Study of the Long-Term Outcomes of HIV-Positive Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000932
First received: November 2, 1999
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Long-Term Clinical, Virologic, and Immunologic Outcomes in HIV-Infected Individuals

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Clinical disease progression or death [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Selected metabolic, hepatic, and cardiovascular conditions [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Changes in viral load [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Changes in CD4 count [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Changes in HIV treatment methods [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 3669
Study Start Date: March 1999
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Participants currently enrolled in or currently being followed in an ongoing qualifying study. Qualifying studies can be found in the protocol.
B
Participants previously enrolled in but not currently being followed in a qualifying study. Qualifying studies can be found in the protocol.
C
Antiretroviral-naive participants not enrolling in a qualifying study (i.e., patients starting treatment outside the first study or patients deferring 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.]

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

HIV infected individuals

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are 13 years of age or older (consent of parent or guardian required if under the age of 18).
  • Are HIV-positive.
  • Have either: (1) no previous experience with anti-HIV treatment (defined as no previous protease inhibitor or nonnucleoside reverse transcriptase inhibitor use, 1 week or less of lamivudine use, and 4 weeks or less of cumulative nucleoside reverse transcriptase inhibitor use) or (2) current or previous enrollment in a qualifying CPCRA study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000932

  Hide Study Locations
Locations
United States, California
Dr. M. Estes Med. Practice CRS
Mill Valley, California, United States, 94941-3013
Dr. Robert Scott Med. Practice CRS
Oakland, California, United States, 94609
East Bay AIDS Ctr. CRS
Oakland, California, United States, 94609
Castro-Mission Health Ctr. CRS
San Francisco, California, United States, 94114
Dr. Shawn Hassler Med. Practice CRS
San Francisco, California, United States, 94102
Dr. Virginia Cafaro Med. Practice CRS
San Francisco, California, United States, 94114-1010
Dr. William Owen Med. Practice CRS
San Francisco, California, United States, 94114-1010
Dr. Martin Mass Med. Practice CRS
San Francisco, California, United States, 94114
Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS
San Francisco, California, United States, 94110
San Francisco VAMC, Infectious Diseases Clinic CRS
San Francisco, California, United States, 94121
St. Mary's Med. Ctr. of San Francisco CRS
San Francisco, California, United States, 94117
UCSF PHP, Gen. Internal Medicine Practice CRS
San Francisco, California, United States, 94143
United States, Colorado
Beacon Clinic at Boulder CRS
Boulder, Colorado, United States, 80501-4507
APEX Family Medicine CRS
Denver, Colorado, United States, 80206
Denver Infectious Diseases Consultants CRS
Denver, Colorado, United States, 80204-4507
Denver Public Health CRS
Denver, Colorado, United States, 80204
Denver Public Health CRS - INSIGHT
Denver, Colorado, United States
Eastside Family Health Ctr. CRS
Denver, Colorado, United States, 80205
Kaiser Permanente of Denver CRS
Denver, Colorado, United States, 80204-4507
South Denver Infectious Diseases Specialists, Accord Med. Ctr. CRS
Denver, Colorado, United States, 80218
Univ. of Colorado Health Science Ctr. CRS
Denver, Colorado, United States, 80204-4507
Western Infectious Disease Consultants CRS
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Univ. of Connecticut Health Ctr. CRS
Farmington, Connecticut, United States, 06030
Hosp. of St. Raphael CRS
New Haven, Connecticut, United States, 06511
Yale Univ. School of Medicine, NE ProACT - New Haven CRS
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Dotson & Hodge Med. Group, L.L.C. CRS
Washington, District of Columbia, United States, 20003
Dr. Timothy A. Price Med. Practice CRS
Washington, District of Columbia, United States, 20036
Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
Washington, District of Columbia, United States, 20422
United States, Illinois
Northwestern Memorial Physicians Group CRS
Chicago, Illinois, United States, 60657
Cook County Hosp. CORE Ctr. INSIGHT CRS
Chicago, Illinois, United States, 60612
Triad Health Practice/Ill. Masonic Med. Ctr. CRS
Chicago, Illinois, United States, 60657
Lakeshore Infectious Disease Associates CRS
Chicago, Illinois, United States, 60657
North Side Family Medicine CRS
Chicago, Illinois, United States, 60657
Cook County Hosp. CORE Ctr.
Chicago, Illinois, United States, 60612
Klein & Slotten Medical Associates CRS
Chicago, Illinois, United States, 60610
Univ. of Illinois Family Ctr. for Infectious Disease CRS
Chicago, Illinois, United States, 60612
United States, Louisiana
Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS
Baton Rouge, Louisiana, United States, 70805
James Osterberger, MD (Private Med. Practice) CRS
Baton Rouge, Louisiana, United States, 70808-4390
Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS
New Orleans, Louisiana, United States, 70112
Memorial Med. Ctr., Hematology-Oncology Services CRS
New Orleans, Louisiana, United States, 70115
New Orleans VAMC CRS
New Orleans, Louisiana, United States, 70146
Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
CRI-Boston CRS
Boston, Massachusetts, United States, 02115
CRI-Springfield CRS
Springfield, Massachusetts, United States, 01107
United States, Michigan
Detroit Community Health Connection, Inc. CRS
Detroit, Michigan, United States, 48215
Detroit Community Health Connection-2 CRS
Detroit, Michigan, United States, 48215
Harper Hosp., Detroit CRS
Detroit, Michigan, United States, 48201
Henry Ford Hosp. CRS
Detroit, Michigan, United States, 48202
Wayne State Univ. INSIGHT CRS
Detroit, Michigan, United States, 48201
United States, New Jersey
Cooper Univ. Hosp. CRS
Camden, New Jersey, United States, 08103
ID Care Inc. - Hillsborough CRS
Hillsborough, New Jersey, United States, 08844
Jersey Shore Univ. Med. Ctr. CRS
Neptune, New Jersey, United States, 07754
Cathedral Healthcare System, St. Michael's Med. Ctr. CRS
Newark, New Jersey, United States, 07103
New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS
Newark, New Jersey, United States, 07103
St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS
Paterson, New Jersey, United States, 07503
Raritan Bay Med. Ctr., Perth Amboy Division CRS
Perth Amboy, New Jersey, United States, 08861
ID Care - Randolph CRS
Randolph, New Jersey, United States, 07869
Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS
Union, New Jersey, United States, 07083
The Early Intervention Program at Kennedy Hosp. CRS
Voorhees, New Jersey, United States, 08043
United States, New York
Bronx Prevention Center CRS
Bronx, New York, United States, 10452
Bronx-Lebanon Hosp. Ctr. CRS
Bronx, New York, United States, 10457
Jacobi Med. Ctr.
Bronx, New York, United States, 10461
Jacobi Med. Ctr., Ambulatory Care Pavillion CRS
Bronx, New York, United States, 10461
Montefiore Med. Ctr., AIDS Ctr. CRS
Bronx, New York, United States, 10467
HHC Methadone Maintenance, Treatment Program Unit 1 CRS
New York, New York, United States, 10026
Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)
New York, New York, United States, 10037-1802
St. Vincent Hosp. & Med. Ctr. CRS
New York, New York, United States, 10011
United States, Oregon
Legacy Clinic Emanuel CRS
Portland, Oregon, United States, 97227
Legacy Clinic Good Samaritan CRS
Portland, Oregon, United States, 97210
Kaiser Immune Deficiency Clinic of Portland CRS
Portland, Oregon, United States, 97227
Multnomah County Health Dept., HIV Health Services Ctr. CRS
Portland, Oregon, United States, 97204
Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
Portland, Oregon, United States, 97239
Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS
Portland, Oregon, United States, 97213
The Research & Education Group-Portland CRS
Portland, Oregon, United States, 97210
Kaiser Permanente Lancaster Clinic CRS
Salem, Oregon, United States, 97305
Salem Hosp. CRS
Salem, Oregon, United States, 97301
United States, Pennsylvania
Philadelphia FIGHT - Dr. Jay Kostman CRS
Philadelphia, Pennsylvania, United States, 19107
Temple Univ. School of Medicine CRS
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
Michael E. DeBakey VAMC CRS
Houston, Texas, United States, 77030
Houston AIDS Research Team CRS
Houston, Texas, United States, 77030
Legacy Community Health Services, Inc. CRS
Houston, Texas, United States, 77006
Baylor College of Medicine, Thomas St. Clinic CRS
Houston, Texas, United States, 77030
Thomas Street Clinic CRS
Houston, Texas, United States, 77030
United States, Virginia
Hanover Med. Park (Mechanicsville, VA) CRS
Mechanicsville, Virginia, United States, 23116
Eastern Virginia Med. School, Ctr. for the Comprehensive Care of Immune Deficiency CRS
Norfolk, Virginia, United States, 23507
Petersburg Health Care Alliance CRS
Petersburg, Virginia, United States, 23803
Hunter Holmes McGuire VAMC CRS
Richmond, Virginia, United States, 23249
CrossOver Health Ctr. CRS
Richmond, Virginia, United States, 23224
South Richmond Health Care Ctr. CRS
Richmond, Virginia, United States, 23224
VCU Health Systems, Infectious Disease Clinic CRS
Richmond, Virginia, United States, 23298
Virginia Commonwealth Univ. Medical Ctr. CRS
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Investigators
Study Chair: Jay Kostman
Study Chair: Roberta Luskin-Hawk
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000932     History of Changes
Other Study ID Numbers: CPCRA 060, 10110
Study First Received: November 2, 1999
Last Updated: April 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Prospective Studies
HIV-1
Drug Therapy, Combination
Drug Resistance, Microbial
CD4 Lymphocyte Count
Disease Progression
Treatment Outcome
Genotype
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 18, 2014