Completed

Effects of Discontinuing PCP Prophylaxis in Patients with CD4 Counts > 200 Cells/mm3 on Antiretroviral Therapies

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What is being collected

Data Collection

Who is being recruted

Blood-Borne Infections+22

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Natural History

Observing the progression of a disease in untreated individuals in order to understand its typical course and outcomes.
Observational
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleImpact of Discontinuing PCP Prophylaxis in Subjects Receiving Antiretroviral Therapies Who Have Had Increases in CD4 Counts to > 200 Cells/mm3
NCT00000908
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

250 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Natural History

These studies observe how a disease progresses over time without active treatment. They help researchers understand how conditions typically develop, change, and impact quality of life.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsLung DiseasesLung Diseases, FungalMycosesOpportunistic InfectionsPneumoniaPneumonia, PneumocystisRespiratory Tract DiseasesRespiratory Tract InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus InfectionsPneumocystis InfectionsAIDS-Related Opportunistic Infections

Criteria

5 inclusion criteria required to participate
Are HIV-positive.

Have had 1 CD4 cell count of less than 100 cells/mm3 and have never had PCP, or have had at least 2 CD4 cell counts over 200 cells/mm3 and have had PCP within 6 months prior to study entry.

Have received PCP prevention medication within 3 months of study entry.

Are at least 13 years old (need consent if under 18).

Show More Criteria

3 exclusion criteria prevent from participating
Have active PCP or symptoms of PCP within 2 weeks of study entry.

Have a fever lasting more than 2 weeks.

Have oral candidiasis (thrush).

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

Suspended

Univ of Alabama at Birmingham

Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google Maps
Suspended

Kaiser Foundation Hosp

Harbor City, United States
Suspended

Kaiser Permanente LAMC

Los Angeles, United States
Suspended

Univ of Southern California / LA County USC Med Ctr

Los Angeles, United States
Completed54 Study Centers