Cryptococcal Optimal ART Timing Trial

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The Cryptococcal Optimal ART Timing (COAT) trial seeks to determine after cryptococcal meningitis (CM) whether early initiation of antiretroviral therapy (ART) prior to hospital discharge results in superior survival compared to standard initiation of ART started as an outpatient.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborators: Makerere University; Mbarara University of Science and Technology; National Institute of Allergy and Infectious Diseases (NIAID); University of Cape Town
• Treatments: Efavirenz; Lamivudine; Stavudine; Zidovudine

Criteria

Inclusion Criteria:

• HIV-infection, documented by ELISA

• Antiretroviral medication naïve (excluding mother-to-child transmission therapy)

• Age >14 years

• Cryptococcal meningitis diagnosed by either culture or CSF cryptococcal antigen (CRAG)

• Ability and willingness of the participant or legal guardian/representative to give informed consent.

• Receiving amphotericin-based anti-fungal therapy

Exclusion Criteria:

• Study entry prior to receipt of <7 days or >11 days of amphotericin therapy

• History of prior, known cryptococcal meningitis

• Inability to take enteral medication

• Receiving chemotherapy or other immunosuppressant medications

• Cannot or unlikely to attend regular clinic visits

• Contraindication to immediate or delayed HIV therapy based on serious co-morbidities or co-infections, or laboratory values

• Pregnancy or Breastfeeding

• Female participants of childbearing potential who are participating in sexual activity that could lead to pregnancy must agree to use two reliable methods of contraception