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Optimal Time to Start Antiretroviral Therapy in HIV-infected Adults With Cryptococcal Meningitis

NCT00976040 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-02-07

No results posted yet for this study

Summary

The goal of this randomized clinical trial is to compare early versus standard timing of initiation of antiretroviral therapy (ART) with respect to clearance of Cryptococcus neoformans from cerebrospinal fluid (CSF) among HIV-infected adults with Cryptococcal Meningitis.

The investigators hypothesize that early ART mediates more rapid clearance of C. neoformans from CSF, as manifested by a greater rate of decrease in C. neoformans colony forming units (CFUs) during the first 28 days after initiating antifungal treatment.

Secondary hypotheses are that recovery of pathogen specific cellular immunity directed at C. neoformans, as manifested by increases in the number and function of C. neoformans-specific peripheral blood mononuclear cells is associated with 1) ART and 2) pathogen clearance. In addition, patients randomized to the intervention arm will have more rapid clearance of antigen levels in CSF and serum and will have a lower incidence of grade 3 and 4 Adverse events.

Conditions

  • Cryptococcal Meningitis
  • HIV Infections

Interventions

OTHER

Early antiretroviral therapy

The intervention is early initiation of antiretroviral therapy after diagnosis of Cryptococcal meningitis. In the intervention/experimental arm, triple-drug highly active antiretroviral therapy regimens will be initiated within 7 days of diagnosis of Cryptococcal meningitis.

Sponsors & Collaborators

  • Doris Duke Charitable Foundation

    collaborator OTHER

  • University of Pennsylvania

    collaborator OTHER

  • Botswana-UPenn Partnership

    lead OTHER

Principal Investigators

  • Gregory P Bisson, MD,MSCE · Botswana-UPenn Partnership, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania

  • Pablo Tebas, MD · Botswana-UPenn Partnership, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-11-30
Completion
2011-12-31

Countries

  • Botswana

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00976040 on ClinicalTrials.gov