The purpose of this study is to learn how the body responds to HIV infection and its treatment over several years. Doctors hope to learn what combinations of anti-HIV drugs work best in patients treated over several years. They also hope to learn about side effects and opportunistic (AIDS-related) infections and how they differ in patients with low viral load (level of HIV in the blood) from those whose viral load is higher.

Condition
HIV Infections

Further Study Details: 

Expected Total Enrollment:  3500

Based on present and recently completed studies, a compilation of outcomes of various therapies would be beneficial when evaluating which strategies are most effective in long-term treatment of HIV-1. This study will correlate therapies with the achievement of, or maintenance of, durable suppression of HIV-1 replication to levels below the limit of detection.

No treatment is provided by this study, but patients continue with antiretroviral therapy from other studies in which they are co-enrolled. Blood specimens are collected at study entry and every 16 weeks over a 4-year period to monitor virologic and immunologic outcomes. Pelvic exams and Pap smears may be done for women. Portions of blood samples will be stored to evaluate genotypic/phenotypic susceptibility testing. Medical histories, physical exams, and questionnaires are done periodically for long-term clinical assessment. The immunologic and clinical outcomes and complications associated with the success or failure of prolonged use of potent antiretroviral therapies will be examined.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.
• Are at least 13 years old (consent of parent or guardian required if under 18).
• Are currently enrolled in an AACTG or PACTG-approved study, are about to enroll in one, or have completed one within the past 8 weeks.
• Will allow use of data from an AACTG or PACTG study.
• Have a life expectancy of at least 24 weeks.
• [This study has been changed to include patients participating in PACTG clinical trials.]

Exclusion Criteria

Patients will not be eligible for this study if they:

• Actively abuse drugs to the point that they are unable to keep appointments.

Alabama
      Univ of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States; Recruiting
California
      Univ of California / San Diego Treatment Ctr, San Diego,  California,  921036325,  United States; Recruiting
      Univ of California, San Francisco/San Francisco General Hosp, San Francisco,  California,  94110,  United States; Recruiting
      Stanford Univ Med Ctr, Stanford,  California,  943055107,  United States; Recruiting
      UCLA CARE Ctr, Los Angeles,  California,  90095,  United States; Recruiting
      Univ of Southern California / LA County USC Med Ctr, Los Angeles,  California,  900331079,  United States; Recruiting
      Harbor UCLA Med Ctr, Torrance,  California,  90502,  United States; Recruiting
      San Mateo AIDS Program / Stanford Univ, Stanford,  California,  943055107,  United States; Recruiting
      Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium, San Jose,  California,  951282699,  United States; Recruiting
      Marin County Specialty Clinic, San Rafael,  California,  94903,  United States; No longer recruiting
      Willow Clinic, Menlo Park,  California,  94025,  United States; Recruiting
      Kaiser Permanente LAMC, Los Angeles,  California,  90027,  United States; No longer recruiting
      UC Davis Med Ctr, Sacramento,  California,  95814,  United States; Recruiting
Colorado
      Univ of Colorado Health Sciences Ctr, Denver,  Colorado,  80262,  United States; Recruiting
District of Columbia
      Georgetown Univ Med Ctr, Washington,  District of Columbia,  20007,  United States; Recruiting
Florida
      Univ of Miami School of Medicine, Miami,  Florida,  331361013,  United States; Recruiting
Georgia
      Emory Univ, Atlanta,  Georgia,  30308,  United States; Recruiting
      Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr, Atlanta,  Georgia,  303652225,  United States; No longer recruiting
Hawaii
      Univ of Hawaii, Honolulu,  Hawaii,  96816,  United States; Recruiting
      Tripler Army Med Ctr, Tripler AMC,  Hawaii,  96859,  United States; Recruiting
Illinois
      Northwestern Univ Med School, Chicago,  Illinois,  60611,  United States; Recruiting
      Rush Presbyterian - Saint Luke's Med Ctr, Chicago,  Illinois,  60612,  United States; Recruiting
      Cook County Hosp, Chicago,  Illinois,  60612,  United States; Recruiting
Indiana
      Indiana Univ Hosp, Indianapolis,  Indiana,  462025250,  United States; Recruiting
      Methodist Hosp of Indiana / Life Care Clinic, Indianapolis,  Indiana,  46202,  United States; Recruiting
      Division of Inf Diseases/ Indiana Univ Hosp, Indianapolis,  Indiana,  46202,  United States; Recruiting
Iowa
      Univ of Iowa Hosp and Clinic, Iowa City,  Iowa,  52242,  United States; Recruiting
Louisiana
      Tulane Med Ctr Hosp, New Orleans,  Louisiana,  70112,  United States; No longer recruiting
Maryland
      Johns Hopkins Hosp, Baltimore,  Maryland,  21287,  United States; Recruiting
      Univ of Maryland, Institute of Human Virology, Baltimore,  Maryland,  21201,  United States; Recruiting
Massachusetts
      Harvard (Massachusetts Gen Hosp), Boston,  Massachusetts,  02114,  United States; Recruiting
      Beth Israel Deaconess - West Campus, Boston,  Massachusetts,  02215,  United States; Recruiting
      Boston Med Ctr, Boston,  Massachusetts,  02118,  United States; Recruiting
      Brigham and Women's Hosp, Boston,  Massachusetts,  02115,  United States; Recruiting
Minnesota
      Univ of Minnesota, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Missouri
      St Louis Regional Hosp / St Louis Regional Med Ctr, St. Louis,  Missouri,  63112,  United States; No longer recruiting
Nebraska
      Univ of Nebraska Med Ctr, Omaha,  Nebraska,  681985130,  United States; Recruiting
New York
      Univ of Rochester Medical Center, Rochester,  New York,  14642,  United States; Recruiting
      Bellevue Hosp / New York Univ Med Ctr, New York,  New York,  10016,  United States; Recruiting
      Mount Sinai Med Ctr, New York,  New York,  10029,  United States; Recruiting
      Cornell Univ Med Ctr, New York,  New York,  10021,  United States; Recruiting
      SUNY / Erie County Med Ctr at Buffalo, Buffalo,  New York,  14215,  United States; Recruiting
      Beth Israel Med Ctr, New York,  New York,  10003,  United States; Recruiting
      Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ, New York,  New York,  10021,  United States; Recruiting
      Columbia Presbyterian Med Ctr, New York,  New York,  10032,  United States; Recruiting
      Chelsea Ctr, New York,  New York,  10021,  United States; Recruiting
      Community Health Network Inc, Rochester,  New York,  14642,  United States; Recruiting
North Carolina
      Carolinas Med Ctr, Charlotte,  North Carolina,  28203,  United States; No longer recruiting
      Univ of North Carolina, Chapel Hill,  North Carolina,  275997215,  United States; Recruiting
      Moses H Cone Memorial Hosp, Greensboro,  North Carolina,  27401,  United States; Recruiting
      Duke Univ Med Ctr, Durham,  North Carolina,  27710,  United States; Recruiting
Ohio
      Univ of Cincinnati, Cincinnati,  Ohio,  452670405,  United States; Recruiting
      Ohio State Univ Hosp Clinic, Columbus,  Ohio,  432101228,  United States; Recruiting
      MetroHealth Med Ctr, Cleveland,  Ohio,  441091998,  United States; Recruiting
      Cleveland Clinic, Cleveland,  Ohio,  44106-5083,  United States; No longer recruiting
Pennsylvania
      Univ of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
      Univ of Pennsylvania at Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
      Presbyterian Medical Center - Univ. of PA, Norristown,  Pennsylvania,  19401,  United States; Recruiting
South Carolina
      Julio Arroyo, West Columbia,  South Carolina,  29169,  United States; Recruiting
Tennessee
      Vanderbilt Univ Med Ctr, Nashville,  Tennessee,  37203,  United States; No longer recruiting
Texas
      Univ of Texas, Southwestern Med Ctr of Dallas, Dallas,  Texas,  75390,  United States; Recruiting
Washington
      Univ of Washington, Seattle,  Washington,  98104,  United States; Recruiting
Puerto Rico
      Univ of Puerto Rico, San Juan,  009365067,  Puerto Rico; Recruiting

Study chairs or principal investigators

Constance Benson,  Study Chair
Ann Collier,  Study Chair

Study ID Numbers:  ACTG A5001; AACTG A5001
Record last reviewed:  January 2005
Last Updated:  April 7, 2005
Record first received:  January 28, 2000
ClinicalTrials.gov Identifier:  NCT00001137
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08