HIV Infections Clinical Trial
Official title:
Study of Pathogen-Specific Immune Responses and General Immune Competence in Opportunistic Infections
NCT number | NCT00005572 |
Other study ID # | ACTG A5067 |
Secondary ID | AACTG A5067 |
Status | Completed |
Phase | N/A |
First received | April 28, 2000 |
Last updated | July 31, 2008 |
The purpose of this study is to understand how changes in the immune system of HIV-infected patients affect their risk for 3 serious infections: Pneumocystis carinii pneumonia (PCP), cytomegalovirus (CMV) retinitis, or CMV organ disease. The purpose also is to understand how anti-HIV medicines may improve the immune system in these patients. (This purpose reflects a change in the AIDS-related [opportunistic] infections studied.) Presently, HIV-infected patients who have had PCP or CMV disease stay on lifelong therapy to prevent the return of the disease. This study is trying to see if a special lab test can help identify which patients can stop this preventive therapy without having another episode of PCP or CMV organ disease. (This rationale reflects a change in the AIDS-related infections studied.)
Status | Completed |
Enrollment | 90 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 13 Years and older |
Eligibility |
Inclusion Criteria Patients may be eligible if they: - Are HIV positive (except Group 3b). - Are at least 13 years old (consent of parent or guardian required if under 18). - Patients may be eligible for Group 1a if they: - Have acute PCP. - Have never received potent anti-HIV drugs or have not received potent anti-HIV drugs for at least 8 weeks prior to getting PCP. - Have a CD4 cell count below 200 cells/mm3. - Patients may be eligible for Group 1b if they: - Have CMV disease. - Meet 1 of the following requirements: (1) have never received potent anti-HIV drug containing a protease inhibitor (PI) or a nonnucleoside reverse transcriptase inhibitor (NNRTI), (2) have not received potent anti-HIV drugs for at least 8 weeks before getting CMV disease, or (3) have been on stable anti-HIV therapy for at least 3 months with no new anti-HIV drugs started before CMV disease returned. - Have a CD4 cell count below 50 cells/mm3 if patient received anti-HIV drugs at any time in the past. - Have an eye exam (patients with CMV retinitis). - Patients may be eligible for Group 2a if they: - Have a history of PCP. - Are currently receiving potent anti-HIV drugs. - Have been enrolled in ACTG 888. - Have been off drugs to prevent PCP for at least 48 weeks prior to study entry. - Have not developed PCP while on potent anti-HIV drugs. - Have a CD4 cell count above 200 cells/mm3. - Patients may be eligible for Group 2b if they: - Have a history of CMV retinitis. - Are currently receiving potent anti-HIV drugs. - Have been off drugs to prevent CMV retinitis for at least 12 weeks prior to study entry. - Have not developed CMV retinitis while on potent anti-HIV drugs. - Have a CD4 cell count above 50 cells/mm3. - Have an eye exam confirming lack of CMV retinitis activity within 28 days before study entry. - Patients may be eligible for Group 3a if they: - Are CMV-positive. - Have never had PCP or CMV disease. - Have never had a CD4 count below 200 cells/mm3. - Have never taken medications to prevent PCP or CMV disease. - Patients may be eligible for Group 3b if they: - Are HIV-negative. - Are CMV-positive. - (The lay eligibility section reflects changes in the AIDS-related infections treated.) Exclusion Criteria Patients will not be eligible if they: - Have received a vaccine within 14 days of study entry or plan to receive one during the study. - Have taken GM-CSF, any investigational drugs, or any drugs that might affect the immune system within 30 days of study entry or plan to take 1 of these medications during the study. (Prednisone for patients with PCP and G-CSF is allowed.) - Abuse drugs. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hosp | Baltimore | Maryland |
United States | Children's Mem Hosp Family Cln / Northwestern Univ Med Schl | Chicago | Illinois |
United States | Rush Presbyterian - Saint Luke's Med Ctr | Chicago | Illinois |
United States | Univ of Cincinnati | Cincinnati | Ohio |
United States | Univ of Colorado Health Sciences Ctr | Denver | Colorado |
United States | Methodist Hosp of Indiana / Life Care Clinic | Indianapolis | Indiana |
United States | Wishard Hosp | Indianapolis | Indiana |
United States | Univ of Southern California / LA County USC Med Ctr | Los Angeles | California |
United States | Bellevue Hosp / New York Univ Med Ctr | New York | New York |
United States | Beth Israel Med Ctr | New York | New York |
United States | Univ of Pennsylvania at Philadelphia | Philadelphia | Pennsylvania |
United States | Univ of California / San Diego Treatment Ctr | San Diego | California |
United States | San Francisco Gen Hosp | San Francisco | California |
United States | Marin County Specialty Clinic | San Rafael | California |
United States | Univ of Washington | Seattle | Washington |
United States | Julio Arroyo | West Columbia | South Carolina |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
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