A Comparison of HIV-Infected Patients With and Without Opportunistic (AIDS-Related) Infection

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.