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

A Prospective Study of Long-Term Clinical, Virologic, and Immunologic Outcomes in HIV-Infected Individuals

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections

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.]

• Study Type: Observational
• Enrollment (Actual): 3669

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

HIV infected individuals

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical disease progression or death	Throughout study

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: Jay Kostman; Study Chair: Roberta Luskin-Hawk

Publications and helpful links

General Publications

• Goetz MB, Leduc R, Kostman JR, Labriola AM, Lie Y, Weidler J, Coakley E, Bates M, Luskin-Hawk R; Long-Term Monitoring Study (CPCRA 060) and Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). Relationship between HIV coreceptor tropism and disease progression in persons with untreated chronic HIV infection. J Acquir Immune Defic Syndr. 2009 Mar 1;50(3):259-66. doi: 10.1097/QAI.0b013e3181989a8b. Erratum In: J Acquir Immune Defic Syndr. 2009 May 1;51(1):110.

Study record dates

Study Major Dates

• Study Start: March 1, 1999
• Primary Completion (ACTUAL): September 1, 2006
• Study Completion (ACTUAL): September 1, 2006

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (ESTIMATE): August 31, 2001

Study Record Updates

• Last Update Posted (ESTIMATE): April 15, 2014
• Last Update Submitted That Met QC Criteria: April 14, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Drug Therapy, Combination; Anti-HIV Agents; HIV-1; Viral Load; Prospective Studies; Genotype; CD4 Lymphocyte Count; Disease Progression; Treatment Outcome; Drug Resistance, Microbial
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: CPCRA 060; 10110 (REGISTRY: DAIDS ES number)