A Comparison of HIV-Infected Patients With and Without Opportunistic (AIDS-Related) Infection
Cytomegalovirus Infections, Cytomegalovirus Retinitis, Pneumonia, Pneumocystis Carinii
About this trial
This is an observational trial for Cytomegalovirus Infections focused on measuring AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Lymphocytes, Histoplasmosis, Recurrence, Cytomegalovirus Retinitis, Cell Division, Immunocompetence, Anti-HIV Agents
Eligibility Criteria
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.
Sites / Locations
- Univ of Southern California / LA County USC Med Ctr
- Univ of California / San Diego Treatment Ctr
- San Francisco Gen Hosp
- Marin County Specialty Clinic
- Univ of Colorado Health Sciences Ctr
- Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
- Rush Presbyterian - Saint Luke's Med Ctr
- Methodist Hosp of Indiana / Life Care Clinic
- Wishard Hosp
- Johns Hopkins Hosp
- Beth Israel Med Ctr
- Bellevue Hosp / New York Univ Med Ctr
- Univ of Cincinnati
- Univ of Pennsylvania at Philadelphia
- Julio Arroyo
- Univ of Washington