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Early Versus Delayed Antiretroviral Therapy (ART) in the Treatment of Cryptococcal Meningitis in Africa

NCT00830856 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2016-07-18

No results posted yet for this study

Summary

Cryptococcal Meningitis continues to be one of the most devastating AIDS defining illness in sub-Saharan Africa. Despite the availability of azoles such as fluconazole for treatment, mortality remains high with some studies showing 100% mortality. The investigators designed a study to determine if timing of the initiation of antiretroviral therapy (ART) in patients with cryptococcal meningitis and HIV would improve survival. The investigators hypothesis was that early initiation of ART result in improved mortality for patients with HIV and cryptococcal meningitis.

Conditions

  • Cryptococcal Meningitis
  • HIV Infections

Interventions

DRUG

Fluconazole

Fluconazole 800mg po qday

DRUG

Fixed dose - Stavudine, lamivudine and Nevirapine

Initiation within 72 hours of diagnosis of Cryptococcal meningitis.

DRUG

Fixed dose - Stavudine, Lamivudine, Nevirapine

Delayed initiation of ART defined as 10 weeks after initiation of high dose fluconazole therapy.

Sponsors & Collaborators

  • AIDS Care Research in Africa

    collaborator OTHER

  • University of Zimbabwe

    lead OTHER

Principal Investigators

  • Chiratidzo E Ndhlovu, MBChB, FRCP · University of Zimbabwe, Department of Medicine

  • Azure T Makadzange, MD, DPhil · University of Zimbabwe, Department of Immunology

  • James Hakim, MBChB, FRCP · University of Zimbabwe, Department of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-10-31
Completion
2009-10-31

Countries

  • Zimbabwe

Study Locations

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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 NCT00830856 on ClinicalTrials.gov