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

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; 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:  October 2004
Record first received:  January 28, 2000
ClinicalTrials.gov Identifier:  NCT00001137
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08