A Study to Evaluate the Impact of Stopping Treatment for the Prevention of Pneumonia in HIV-Positive Patients Receiving Anti-HIV Drugs Who Have Increased CD4 Cell Counts

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

The risk of developing PCP may be decreased with treatment-induced recovery of CD4 counts to \> 200 cells/mm3. Few data exist to confirm or negate the continued necessity of PCP prophylaxis for such patients. This study will assess the effects of discontinuing therapy.

Subjects are asked to discontinue PCP prophylaxis if antiretroviral therapy has resulted in a sustained CD4 increase greater than 200 cells/mm3 on two measurements at least 12 weeks apart. They will be evaluated for symptoms and CD4 counts every 8 weeks as well as plasma for HIV-RNA every 16 weeks for 18 months. Subjects who...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• You may be eligible for this study if you:
• • 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).
• • Are taking anti-HIV (antiretroviral) medication at study entry.
• • Exclusion Criteria
• You will not be eligible for this study if you:
• • 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).

Trial Officials