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NCT00000932 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000932
Other study ID # CPCRA 060
Secondary ID 10110
Status Completed
Phase N/A
First received November 2, 1999
Last updated April 14, 2014
Start date March 1999
Est. completion date September 2006

Study information
Verified date April 2014
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 3669
Est. completion date September 2006
Est. primary completion date September 2006
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS Baton Rouge Louisiana
United States James Osterberger, MD (Private Med. Practice) CRS Baton Rouge Louisiana
United States CRI-Boston CRS Boston Massachusetts
United States Beacon Clinic at Boulder CRS Boulder Colorado
United States Bronx Prevention Center CRS Bronx New York
United States Bronx-Lebanon Hosp. Ctr. CRS Bronx New York
United States Jacobi Med. Ctr. Bronx New York
United States Jacobi Med. Ctr., Ambulatory Care Pavillion CRS Bronx New York
United States Montefiore Med. Ctr., AIDS Ctr. CRS Bronx New York
United States Cooper Univ. Hosp. CRS Camden New Jersey
United States Cook County Hosp. CORE Ctr. Chicago Illinois
United States Cook County Hosp. CORE Ctr. INSIGHT CRS Chicago Illinois
United States Klein & Slotten Medical Associates CRS Chicago Illinois
United States Lakeshore Infectious Disease Associates CRS Chicago Illinois
United States North Side Family Medicine CRS Chicago Illinois
United States Northwestern Memorial Physicians Group CRS Chicago Illinois
United States Triad Health Practice/Ill. Masonic Med. Ctr. CRS Chicago Illinois
United States Univ. of Illinois Family Ctr. for Infectious Disease CRS Chicago Illinois
United States APEX Family Medicine CRS Denver Colorado
United States Denver Infectious Diseases Consultants CRS Denver Colorado
United States Denver Public Health CRS Denver Colorado
United States Denver Public Health CRS - INSIGHT Denver Colorado
United States Eastside Family Health Ctr. CRS Denver Colorado
United States Kaiser Permanente of Denver CRS Denver Colorado
United States South Denver Infectious Diseases Specialists, Accord Med. Ctr. CRS Denver Colorado
United States Univ. of Colorado Health Science Ctr. CRS Denver Colorado
United States Detroit Community Health Connection, Inc. CRS Detroit Michigan
United States Detroit Community Health Connection-2 CRS Detroit Michigan
United States Harper Hosp., Detroit CRS Detroit Michigan
United States Henry Ford Hosp. CRS Detroit Michigan
United States Wayne State Univ. INSIGHT CRS Detroit Michigan
United States Univ. of Connecticut Health Ctr. CRS Farmington Connecticut
United States ID Care Inc. - Hillsborough CRS Hillsborough New Jersey
United States Baylor College of Medicine, Thomas St. Clinic CRS Houston Texas
United States Houston AIDS Research Team CRS Houston Texas
United States Legacy Community Health Services, Inc. CRS Houston Texas
United States Michael E. DeBakey VAMC CRS Houston Texas
United States Thomas Street Clinic CRS Houston Texas
United States Hanover Med. Park (Mechanicsville, VA) CRS Mechanicsville Virginia
United States Dr. M. Estes Med. Practice CRS Mill Valley California
United States Jersey Shore Univ. Med. Ctr. CRS Neptune New Jersey
United States Hosp. of St. Raphael CRS New Haven Connecticut
United States Yale Univ. School of Medicine, NE ProACT - New Haven CRS New Haven Connecticut
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 New Orleans VAMC CRS New Orleans Louisiana
United States Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS New Orleans Louisiana
United States Harlem Hospital Ctr./Columbia University CRS (Gordin CTU) New York New York
United States HHC Methadone Maintenance, Treatment Program Unit 1 CRS New York New York
United States St. Vincent Hosp. & Med. Ctr. CRS New York New York
United States Cathedral Healthcare System, St. Michael's Med. Ctr. CRS Newark New Jersey
United States New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS Newark New Jersey
United States Eastern Virginia Med. School, Ctr. for the Comprehensive Care of Immune Deficiency CRS Norfolk Virginia
United States Dr. Robert Scott Med. Practice CRS Oakland California
United States East Bay AIDS Ctr. CRS Oakland California
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 Petersburg Health Care Alliance CRS Petersburg Virginia
United States Philadelphia FIGHT - Dr. Jay Kostman CRS Philadelphia Pennsylvania
United States Temple Univ. School of Medicine CRS Philadelphia Pennsylvania
United States Kaiser Immune Deficiency Clinic of Portland CRS Portland Oregon
United States Legacy Clinic Emanuel CRS Portland Oregon
United States Legacy Clinic Good Samaritan CRS Portland Oregon
United States Multnomah County Health Dept., HIV Health Services Ctr. CRS Portland Oregon
United States Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS Portland Oregon
United States Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS Portland Oregon
United States The Research & Education Group-Portland CRS Portland Oregon
United States ID Care - Randolph CRS Randolph New Jersey
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 Kaiser Permanente Lancaster Clinic CRS Salem Oregon
United States Salem Hosp. CRS Salem Oregon
United States Castro-Mission Health Ctr. CRS San Francisco California
United States Dr. Martin Mass Med. Practice CRS San Francisco California
United States Dr. Shawn Hassler Med. Practice CRS San Francisco California
United States Dr. Virginia Cafaro Med. Practice CRS San Francisco California
United States Dr. William Owen Med. Practice CRS San Francisco California
United States Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS San Francisco California
United States San Francisco VAMC, Infectious Diseases Clinic CRS San Francisco California
United States St. Mary's Med. Ctr. of San Francisco CRS San Francisco California
United States UCSF PHP, Gen. Internal Medicine Practice CRS San Francisco California
United States CRI-Springfield CRS Springfield Massachusetts
United States Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS Union New Jersey
United States The Early Intervention Program at Kennedy Hosp. CRS Voorhees New Jersey
United States Dotson & Hodge Med. Group, L.L.C. CRS Washington District of Columbia
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 Western Infectious Disease Consultants CRS Wheat Ridge Colorado

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 a — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical disease progression or death Throughout study Yes
Secondary Survival Throughout study Yes
Secondary Selected metabolic, hepatic, and cardiovascular conditions Throughout study No
Secondary Changes in viral load Throughout study No
Secondary Changes in CD4 count Throughout study No
Secondary Changes in HIV treatment methods Throughout study No
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