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Ensayos clínicos

Ensayos clínicos

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

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000932, CPCRA 060
  • Concluido

Propósito del estudio

To compare rates, within individual CPCRA clinical trials, of morbidity and mortality in patients randomized to different HIV treatment or management strategies: (1) CPCRA 058, FIRST: To compare 3 strategies of first-time HAART for delaying disease progression and death. (2) CPCRA 059, interleukin-2 (IL-2): To compare the effect of subcutaneous IL-2 plus antiretroviral therapy versus antiretroviral therapy alone in delaying disease progression and death. (3) CPCRA 042, NvR: To compare the effect of 2 antiretroviral treatments, 1 starting with combination therapy including nelfinavir (NFV) and the other starting with combination therapy including ritonavir (RTV), in delaying disease progression and death [AS PER AMENDMENT 2/28/01: in delaying mortality] in HIV-infected patients with CD4 cell counts less than 200 cells/mm3. (4) CPCRA 057, PIP: To compare the effects of using efavirenz (EFV) alone, with a single protease inhibitor (PI) or with a double PI on disease progression and death among patients failing on NFV, indinavir (IDV), or RTV. (5) CPCRA 046 and 039, GART and bis-POM: To evaluate the prognostic importance for delaying disease progression and death of genotypic resistance patterns. [AS PER AMENDMENT 2/28/01: The fourth and fifth objectives listed above are no longer included. (6) CPCRA 064, MDR-HIV: To compare the effect of a strategy of prescribing a 4-month antiretroviral structured treatment interruption followed by initiating a new antiretroviral regimen versus a strategy of immediately initiating a new antiretroviral regimen in delaying mortality in patients with multidrug-resistant HIV. (7) All other qualifying protocols: To compare the effects of the randomized interventions in delaying disease progression and death.]

Afección:
Infecciones por el VIH

Detalles del estudio

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.]

Centros de estudio/contactos

California

    Dr. M. Estes Med. Practice CRS, Mill Valley, California, 94941-3013, United States

    Dr. Robert Scott Med. Practice CRS, Oakland, California, 94609, United States

    East Bay AIDS Ctr. CRS, Oakland, California, 94609, United States

    Castro-Mission Health Ctr. CRS, San Francisco, California, 94114, United States

    Dr. Shawn Hassler Med. Practice CRS, San Francisco, California, 94102, United States

    St. Mary's Med. Ctr. of San Francisco CRS, San Francisco, California, 94117, United States

    Dr. William Owen Med. Practice CRS, San Francisco, California, 94114-1010, United States

    Dr. Martin Mass Med. Practice CRS, San Francisco, California, 94114, United States

    Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS, San Francisco, California, 94110, United States

    San Francisco VAMC, Infectious Diseases Clinic CRS, San Francisco, California, 94121, United States

    Dr. Virginia Cafaro Med. Practice CRS, San Francisco, California, 94114-1010, United States

    UCSF PHP, Gen. Internal Medicine Practice CRS, San Francisco, California, 94143, United States

Colorado

    Beacon Clinic at Boulder CRS, Boulder, Colorado, 80501-4507, United States

    APEX Family Medicine CRS, Denver, Colorado, 80206, United States

    Denver Infectious Diseases Consultants CRS, Denver, Colorado, 80204-4507, United States

    Denver Public Health CRS, Denver, Colorado, 80204, United States

    Denver Public Health CRS - INSIGHT, Denver, Colorado, 80204, United States

    Eastside Family Health Ctr. CRS, Denver, Colorado, 80205, United States

    Kaiser Permanente of Denver CRS, Denver, Colorado, 80204-4507, United States

    South Denver Infectious Diseases Specialists, Accord Med. Ctr. CRS, Denver, Colorado, 80218, United States

    Univ. of Colorado Health Science Ctr. CRS, Denver, Colorado, 80204-4507, United States

    Western Infectious Disease Consultants CRS, Wheat Ridge, Colorado, 80033, United States

Connecticut

    Univ. of Connecticut Health Ctr. CRS, Farmington, Connecticut, 06030, United States

    Hosp. of St. Raphael CRS, New Haven, Connecticut, 06511, United States

    Yale Univ. School of Medicine, NE ProACT - New Haven CRS, New Haven, Connecticut, 06510, United States

District of Columbia

    Dotson & Hodge Med. Group, L.L.C. CRS, Washington, District of Columbia, 20003, United States

    Dr. Timothy A. Price Med. Practice CRS, Washington, District of Columbia, 20036, United States

    Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS, Washington, District of Columbia, 20422, United States

Illinois

    Cook County Hosp. CORE Ctr., Chicago, Illinois, 60612, United States

    Cook County Hosp. CORE Ctr. INSIGHT CRS, Chicago, Illinois, 60612, United States

    Triad Health Practice/Ill. Masonic Med. Ctr. CRS, Chicago, Illinois, 60657, United States

    Lakeshore Infectious Disease Associates CRS, Chicago, Illinois, 60657, United States

    North Side Family Medicine CRS, Chicago, Illinois, 60657, United States

    Northwestern Memorial Physicians Group CRS, Chicago, Illinois, 60657, United States

    Klein & Slotten Medical Associates CRS, Chicago, Illinois, 60610, United States

    Univ. of Illinois Family Ctr. for Infectious Disease CRS, Chicago, Illinois, 60612, United States

Louisiana

    Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS, Baton Rouge, Louisiana, 70805, United States

    James Osterberger, MD (Private Med. Practice) CRS, Baton Rouge, Louisiana, 70808-4390, United States

    Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS, New Orleans, Louisiana, 70112, United States

    Memorial Med. Ctr., Hematology-Oncology Services CRS, New Orleans, Louisiana, 70115, United States

    New Orleans VAMC CRS, New Orleans, Louisiana, 70146, United States

    Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS, New Orleans, Louisiana, 70112, United States

Massachusetts

    CRI-Boston CRS, Boston, Massachusetts, 02115, United States

    CRI-Springfield CRS, Springfield, Massachusetts, 01107, United States

Michigan

    Detroit Community Health Connection, Inc. CRS, Detroit, Michigan, 48215, United States

    Detroit Community Health Connection-2 CRS, Detroit, Michigan, 48215, United States

    Harper Hosp., Detroit CRS, Detroit, Michigan, 48201, United States

    Henry Ford Hosp. CRS, Detroit, Michigan, 48202, United States

    Wayne State Univ. INSIGHT CRS, Detroit, Michigan, 48201, United States

New Jersey

    Cooper Univ. Hosp. CRS, Camden, New Jersey, 08103, United States

    ID Care Inc. - Hillsborough CRS, Hillsborough, New Jersey, 08844, United States

    Jersey Shore Univ. Med. Ctr. CRS, Neptune, New Jersey, 07754, United States

    Cathedral Healthcare System, St. Michael's Med. Ctr. CRS, Newark, New Jersey, 07103, United States

    New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS, Newark, New Jersey, 07103, United States

    St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS, Paterson, New Jersey, 07503, United States

    Raritan Bay Med. Ctr., Perth Amboy Division CRS, Perth Amboy, New Jersey, 08861, United States

    ID Care - Randolph CRS, Randolph, New Jersey, 07869, United States

    Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS, Union, New Jersey, 07083, United States

    The Early Intervention Program at Kennedy Hosp. CRS, Voorhees, New Jersey, 08043, United States

New York

    Bronx Prevention Center CRS, Bronx, New York, 10452, United States

    Bronx-Lebanon Hosp. Ctr. CRS, Bronx, New York, 10457, United States

    Jacobi Med. Ctr., Bronx, New York, 10461, United States

    Jacobi Med. Ctr., Ambulatory Care Pavillion CRS, Bronx, New York, 10461, United States

    Montefiore Med. Ctr., AIDS Ctr. CRS, Bronx, New York, 10467, United States

    HHC Methadone Maintenance, Treatment Program Unit 1 CRS, New York, New York, 10026, United States

    Harlem Hospital Ctr./Columbia University CRS (Gordin CTU), New York, New York, 10037-1802, United States

    St. Vincent Hosp. & Med. Ctr. CRS, New York, New York, 10011, United States

Oregon

    Kaiser Immune Deficiency Clinic of Portland CRS, Portland, Oregon, 97227, United States

    Legacy Clinic Good Samaritan CRS, Portland, Oregon, 97210, United States

    Legacy Clinic Emanuel CRS, Portland, Oregon, 97227, United States

    Multnomah County Health Dept., HIV Health Services Ctr. CRS, Portland, Oregon, 97204, United States

    Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS, Portland, Oregon, 97239, United States

    Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS, Portland, Oregon, 97213, United States

    The Research & Education Group-Portland CRS, Portland, Oregon, 97210, United States

    Kaiser Permanente Lancaster Clinic CRS, Salem, Oregon, 97305, United States

    Salem Hosp. CRS, Salem, Oregon, 97301, United States

Pennsylvania

    Philadelphia FIGHT - Dr. Jay Kostman CRS, Philadelphia, Pennsylvania, 19107, United States

    Temple Univ. School of Medicine CRS, Philadelphia, Pennsylvania, 19140, United States

Texas

    Baylor College of Medicine, Thomas St. Clinic CRS, Houston, Texas, 77030, United States

    Houston AIDS Research Team CRS, Houston, Texas, 77030, United States

    Legacy Community Health Services, Inc. CRS, Houston, Texas, 77006, United States

    Michael E. DeBakey VAMC CRS, Houston, Texas, 77030, United States

    Thomas Street Clinic CRS, Houston, Texas, 77030, United States

Virginia

    Hanover Med. Park (Mechanicsville, VA) CRS, Mechanicsville, Virginia, 23116, United States

    Eastern Virginia Med. School, Ctr. for the Comprehensive Care of Immune Deficiency CRS, Norfolk, Virginia, 23507, United States

    Petersburg Health Care Alliance CRS, Petersburg, Virginia, 23803, United States

    Hunter Holmes McGuire VAMC CRS, Richmond, Virginia, 23249, United States

    Virginia Commonwealth Univ. Medical Ctr. CRS, Richmond, Virginia, 23298, United States

    South Richmond Health Care Ctr. CRS, Richmond, Virginia, 23224, United States

    VCU Health Systems, Infectious Disease Clinic CRS, Richmond, Virginia, 23298, United States

    CrossOver Health Ctr. CRS, Richmond, Virginia, 23224, United States

Actualizado: 22 de octubre del 2004

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