Cryptococcal Optimal ART Timing Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01075152
• Date of registration: 23/02/2010
• Prospective Registration: Yes
• Primary sponsor: University of Minnesota
• Public title: Cryptococcal Optimal ART Timing Trial COAT
• Scientific title: Trial for the Optimal Timing of HIV Therapy After Cryptococcal Meningitis
• Date of first enrolment: November 2010
• Target sample size: 177
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01075152
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

South Africa, Uganda

Contacts

• Name: David R Boulware, MD, MPH
• Affiliation: University of Minnesota

Key inclusion & exclusion 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



Age minimum: 14 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

AIDS

Cryptococcal Meningitis

HIV Infections

Intervention(s)

Biological: nucleoside

Drug: efavirenz

Primary Outcome(s)

Mortality [Time Frame: 26 weeks from study entry]

Secondary Outcome(s)

Karnofsky Functional Status [Time Frame: 46 weeks]

Incidence of Immune Reconstitution Inflammatory Syndrome [Time Frame: 46 weeks]

46-week Survival [Time Frame: 46 weeks]

HIV-1 Viral Suppression [Time Frame: 26 weeks]

Antiretroviral Therapy Tolerability [Time Frame: 26 weeks]

Incidence of Cryptococcal-relapse [Time Frame: 46 weeks]

Microbiologic Clearance [Time Frame: 4 weeks]

Safety of ART Initiation [Time Frame: 46 weeks]

Secondary ID(s)

U01AI089244

0810M49622

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Makerere University

National Institute of Allergy and Infectious Diseases (NIAID)

University of Cape Town

Mbarara University of Science and Technology

Results

• Results available: Yes
• Date Posted: 20/08/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01075152