Clinical trial NCT00000932: A Study of the Long-Term Outcomes of HIV-Positive Patients
Official title: A Prospective Study of Long-Term Clinical, Virologic, and Immunologic Outcomes in HIV-Infected Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Prospective Studies
HIV-1
Drug Therapy, Combination
Drug Resistance, Microbial
CD4 Lymphocyte Count
Disease Progression
Treatment Outcome
Genotype
Anti-HIV Agents
Viral Load
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 3669
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV infected individuals

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. \[AS PER AMENDMENT 2/28/01: Patients who are not being followed in a qualifying protocol and are antiretroviral naive at enrollment or were previously enrolled in the FIRST (CPCRA 058) protocol undergo blood draws at enrollment and then annually for measurement of plasma HIV levels by a CPCRA-approved laboratory and future CPCRA-approved, HIV-related research. Patients who relocate to a non-CPCRA affiliated site are asked to sign a consent for ongoing release (every 4 months) of their medical records from their new health care provider to the CPCRA.\]

Eligibility 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.

Primary outcomes:
measure: Clinical disease progression or death
timeFrame: Throughout study
Secondary outcomes:
measure: Survival
timeFrame: Throughout study
measure: Selected metabolic, hepatic, and cardiovascular conditions
timeFrame: Throughout study
measure: Changes in viral load
timeFrame: Throughout study
measure: Changes in CD4 count
timeFrame: Throughout study
measure: Changes in HIV treatment methods
timeFrame: Throughout study
Other outcomes:
Locations:
city: Mill Valley
country: United States
facility: Dr. M. Estes Med. Practice CRS
state: California
city: Oakland
country: United States
facility: Dr. Robert Scott Med. Practice CRS
state: California
city: Oakland
country: United States
facility: East Bay AIDS Ctr. CRS
state: California
city: San Francisco
country: United States
facility: Dr. Shawn Hassler Med. Practice CRS
state: California
city: San Francisco
country: United States
facility: Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS
state: California
city: San Francisco
country: United States
facility: Dr. Virginia Cafaro Med. Practice CRS
state: California
city: San Francisco
country: United States
facility: Dr. William Owen Med. Practice CRS
state: California
city: San Francisco
country: United States
facility: Castro-Mission Health Ctr. CRS
state: California
city: San Francisco
country: United States
facility: Dr. Martin Mass Med. Practice CRS
state: California
city: San Francisco
country: United States
facility: St. Mary's Med. Ctr. of San Francisco CRS
state: California
city: San Francisco
country: United States
facility: San Francisco VAMC, Infectious Diseases Clinic CRS
state: California
city: San Francisco
country: United States
facility: UCSF PHP, Gen. Internal Medicine Practice CRS
state: California
city: Boulder
country: United States
facility: Beacon Clinic at Boulder CRS
state: Colorado
city: Denver
country: United States
facility: Denver Infectious Diseases Consultants CRS
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente of Denver CRS
state: Colorado
city: Denver
country: United States
facility: Univ. of Colorado Health Science Ctr. CRS
state: Colorado
city: Denver
country: United States
facility: Denver Public Health CRS
state: Colorado
city: Denver
country: United States
facility: Eastside Family Health Ctr. CRS
state: Colorado
city: Denver
country: United States
facility: APEX Family Medicine CRS
state: Colorado
city: Denver
country: United States
facility: South Denver Infectious Diseases Specialists, Accord Med. Ctr. CRS
state: Colorado
city: Denver
country: United States
facility: Denver Public Health CRS - INSIGHT
state: Colorado
city: Wheat Ridge
country: United States
facility: Western Infectious Disease Consultants CRS
state: Colorado
city: Farmington
country: United States
facility: Univ. of Connecticut Health Ctr. CRS
state: Connecticut
city: New Haven
country: United States
facility: Yale Univ. School of Medicine, NE ProACT - New Haven CRS
state: Connecticut
city: New Haven
country: United States
facility: Hosp. of St. Raphael CRS
state: Connecticut
city: Washington
country: United States
facility: Dotson & Hodge Med. Group, L.L.C. CRS
state: District of Columbia
city: Washington
country: United States
facility: Dr. Timothy A. Price Med. Practice CRS
state: District of Columbia
city: Washington
country: United States
facility: Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
state: District of Columbia
city: Chicago
country: United States
facility: Klein & Slotten Medical Associates CRS
state: Illinois
city: Chicago
country: United States
facility: Cook County Hosp. CORE Ctr. INSIGHT CRS
state: Illinois
city: Chicago
country: United States
facility: Cook County Hosp. CORE Ctr.
state: Illinois
city: Chicago
country: United States
facility: Univ. of Illinois Family Ctr. for Infectious Disease CRS
state: Illinois
city: Chicago
country: United States
facility: Lakeshore Infectious Disease Associates CRS
state: Illinois
city: Chicago
country: United States
facility: North Side Family Medicine CRS
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Physicians Group CRS
state: Illinois
city: Chicago
country: United States
facility: Triad Health Practice/Ill. Masonic Med. Ctr. CRS
state: Illinois
city: Baton Rouge
country: United States
facility: Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS
state: Louisiana
city: Baton Rouge
country: United States
facility: James Osterberger, MD (Private Med. Practice) CRS
state: Louisiana
city: New Orleans
country: United States
facility: Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS
state: Louisiana
city: New Orleans
country: United States
facility: Memorial Med. Ctr., Hematology-Oncology Services CRS
state: Louisiana
city: New Orleans
country: United States
facility: New Orleans VAMC CRS
state: Louisiana
city: Boston
country: United States
facility: CRI-Boston CRS
state: Massachusetts
city: Springfield
country: United States
facility: CRI-Springfield CRS
state: Massachusetts
city: Detroit
country: United States
facility: Harper Hosp., Detroit CRS
state: Michigan
city: Detroit
country: United States
facility: Wayne State Univ. INSIGHT CRS
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hosp. CRS
state: Michigan
city: Detroit
country: United States
facility: Detroit Community Health Connection, Inc. CRS
state: Michigan
city: Detroit
country: United States
facility: Detroit Community Health Connection-2 CRS
state: Michigan
city: Camden
country: United States
facility: Cooper Univ. Hosp. CRS
state: New Jersey
city: Hillsborough
country: United States
facility: ID Care Inc. - Hillsborough CRS
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore Univ. Med. Ctr. CRS
state: New Jersey
city: Newark
country: United States
facility: Cathedral Healthcare System, St. Michael's Med. Ctr. CRS
state: New Jersey
city: Newark
country: United States
facility: New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS
state: New Jersey
city: Paterson
country: United States
facility: St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS
state: New Jersey
city: Perth Amboy
country: United States
facility: Raritan Bay Med. Ctr., Perth Amboy Division CRS
state: New Jersey
city: Randolph
country: United States
facility: ID Care - Randolph CRS
state: New Jersey
city: Union
country: United States
facility: Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS
state: New Jersey
city: Voorhees
country: United States
facility: The Early Intervention Program at Kennedy Hosp. CRS
state: New Jersey
city: Bronx
country: United States
facility: Bronx Prevention Center CRS
state: New York
city: Bronx
country: United States
facility: Bronx-Lebanon Hosp. Ctr. CRS
state: New York
city: Bronx
country: United States
facility: Jacobi Med. Ctr., Ambulatory Care Pavillion CRS
state: New York
city: Bronx
country: United States
facility: Jacobi Med. Ctr.
state: New York
city: Bronx
country: United States
facility: Montefiore Med. Ctr., AIDS Ctr. CRS
state: New York
city: New York
country: United States
facility: St. Vincent Hosp. & Med. Ctr. CRS
state: New York
city: New York
country: United States
facility: HHC Methadone Maintenance, Treatment Program Unit 1 CRS
state: New York
city: New York
country: United States
facility: Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)
state: New York
city: Portland
country: United States
facility: Multnomah County Health Dept., HIV Health Services Ctr. CRS
state: Oregon
city: Portland
country: United States
facility: Legacy Clinic Good Samaritan CRS
state: Oregon
city: Portland
country: United States
facility: The Research & Education Group-Portland CRS
state: Oregon
city: Portland
country: United States
facility: Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS
state: Oregon
city: Portland
country: United States
facility: Kaiser Immune Deficiency Clinic of Portland CRS
state: Oregon
city: Portland
country: United States
facility: Legacy Clinic Emanuel CRS
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
state: Oregon
city: Salem
country: United States
facility: Salem Hosp. CRS
state: Oregon
city: Salem
country: United States
facility: Kaiser Permanente Lancaster Clinic CRS
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia FIGHT - Dr. Jay Kostman CRS
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple Univ. School of Medicine CRS
state: Pennsylvania
city: Houston
country: United States
facility: Legacy Community Health Services, Inc. CRS
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine, Thomas St. Clinic CRS
state: Texas
city: Houston
country: United States
facility: Houston AIDS Research Team CRS
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VAMC CRS
state: Texas
city: Houston
country: United States
facility: Thomas Street Clinic CRS
state: Texas
city: Mechanicsville
country: United States
facility: Hanover Med. Park (Mechanicsville, VA) CRS
state: Virginia
city: Norfolk
country: United States
facility: Eastern Virginia Med. School, Ctr. for the Comprehensive Care of Immune Deficiency CRS
state: Virginia
city: Petersburg
country: United States
facility: Petersburg Health Care Alliance CRS
state: Virginia
city: Richmond
country: United States
facility: CrossOver Health Ctr. CRS
state: Virginia
city: Richmond
country: United States
facility: South Richmond Health Care Ctr. CRS
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire VAMC CRS
state: Virginia
city: Richmond
country: United States
facility: VCU Health Systems, Infectious Disease Clinic CRS
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth Univ. Medical Ctr. CRS
state: Virginia
Study officials:
name: Jay Kostman
role: STUDY_CHAIR
name: Roberta Luskin-Hawk
role: STUDY_CHAIR
References:
citation: 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.