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

Completed

Conditions studied: Cytomegalovirus Infections, Cytomegalovirus Retinitis, Pneumonia, Pneumocystis Carinii, HIV Infections

In brief

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.)

Key facts

Study ID

NCT00005572

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

90

Last updated by the study team

2008-08-04

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, 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 Colorado Health Sciences Ctr — Denver, Colorado, 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
• Methodist Hosp of Indiana / Life Care Clinic — Indianapolis, Indiana, United States
• Wishard Hosp — Indianapolis, Indiana, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Beth Israel Med Ctr — New York, New York, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Univ of Cincinnati — Cincinnati, Ohio, United States
• Univ of Pennsylvania at Philadelphia — Philadelphia, Pennsylvania, United States
• Julio Arroyo — West Columbia, South Carolina, United States
• Univ of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.