A Comparison of HIV-Infected Patients With and Without Opportunistic (AIDS-Related) Infection (NCT00005572) | Clinical Trial Compass
CompletedNot Applicable
A Comparison of HIV-Infected Patients With and Without Opportunistic (AIDS-Related) Infection
United States90 participants
Plain-language summary
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.)
Who can participate
Age range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00005572
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)