0810M49622

About this trial

Last updated 5 years ago

Study ID

0810M49622

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

Accepting

14+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 12 years ago

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.

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

Cryptococcal Optimal ART Timing Trial