Effects of Discontinuing PCP Prophylaxis in Patients with CD4 Counts > 200 Cells/mm3 on Antiretroviral Therapies
Data Collection
Blood-Borne Infections+22
+ Urogenital Diseases
+ Genital Diseases
Natural History
Observing the progression of a disease in untreated individuals in order to understand its typical course and outcomes.Summary
This study focuses on people living with HIV who are on antiretroviral therapies and have experienced an increase in their CD4 count to over 200 cells/mm3. The main goal is to understand if these individuals still need to continue with a specific preventive treatment, known as PCP prophylaxis, which helps protect against a type of pneumonia called Pneumocystis pneumonia (PCP). The importance of this study lies in determining whether it's safe to stop PCP prophylaxis once the immune system has improved, potentially simplifying treatment plans and reducing unnecessary medication use. Participants in this study will discontinue their PCP prophylaxis if their antiretroviral therapy has led to a sustained increase in their CD4 count above 200 cells/mm3, as confirmed by two measurements taken at least 12 weeks apart. They will then be regularly checked for symptoms and CD4 counts every 8 weeks, and their blood will be tested for HIV-RNA every 16 weeks for a period of 18 months. If a participant's CD4 count drops below certain levels, their CD4 count will be re-evaluated and, if still low, they will resume PCP prophylaxis and continue to be monitored as part of the study. Regular physical exams and laboratory tests will also be conducted at specific intervals to track participants' health.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.250 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Natural History
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 54 locations
Univ of Alabama at Birmingham
Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google MapsKaiser Foundation Hosp
Harbor City, United StatesKaiser Permanente LAMC
Los Angeles, United StatesUniv of Southern California / LA County USC Med Ctr
Los Angeles, United States