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.

Condition
HIV Infections

Further Study Details: 

Expected Total Enrollment:  3700

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.]

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 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.

California
      Community Consortium / UCSF, San Francisco,  California,  94110,  United States
      Lawrence Goldyn, MD, San Francisco,  California,  94110,  United States
      Dr. Shawn Hassler, San Francisco,  California,  94110,  United States
Colorado
      Denver CPCRA / Denver Public Hlth, Denver,  Colorado,  802044507,  United States
Connecticut
      Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit, New Haven,  Connecticut,  065102483,  United States
District of Columbia
      Washington Reg AIDS Prog / Dept of Infect Dis, Washington,  District of Columbia,  20422,  United States
Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  303081962,  United States
Illinois
      AIDS Research Alliance - Chicago, Chicago,  Illinois,  60657,  United States
Louisiana
      Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans,  Louisiana,  70112,  United States
Massachusetts
      Community Research Initiative/ProACT, Springfield,  Massachusetts,  01107,  United States
      Community Research Initiatives/ProACT, Boston,  Massachusetts,  02215,  United States
Michigan
      Henry Ford Hosp, Detroit,  Michigan,  48202,  United States
      Wayne State Univ - WSU/DMC / Univ Hlth Ctr, Detroit,  Michigan,  48201,  United States
New Jersey
      North Jersey Community Research Initiative, Newark,  New Jersey,  071032842,  United States
      Southern New Jersey AIDS Clinical Trials, Camden,  New Jersey,  08103,  United States
New Mexico
      Partners in Research / New Mexico, Albuquerque,  New Mexico,  87131,  United States
New York
      Harlem AIDS Treatment Grp / Harlem Hosp Ctr, New York,  New York,  10037,  United States
Oregon
      The Research and Education Group, Portland,  Oregon,  97210,  United States
Pennsylvania
      Philadelphia FIGHT, Philadelphia,  Pennsylvania,  19107,  United States
      Temple University School of Medicine, Philadelphia,  Pennsylvania,  19140,  United States
Texas
      Univ TX Health Science Ctr, Houston,  Texas,  77030,  United States
      University Clinical Research Center, Houston,  Texas,  77030,  United States
Virginia
      Richmond AIDS Consortium / Div of Infect Diseases, Richmond,  Virginia,  232980049,  United States
      Vernon J. Harris East En Community Health Care Ct, Richmond,  Virginia,  23298,  United States
      Petersburg Health Care Alliance, Richmond,  Virginia,  23298,  United States

Study chairs or principal investigators

Jay Kostman,  Study Chair
Roberta Luskin-Hawk,  Study Chair

Study ID Numbers:  CPCRA 060
Record last reviewed:  October 2004
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000932
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08