Phase 4
N=177
Cryptococcal Optimal ART Timing Trial
Cryptococcal Meningitis · HIV Infections · AIDS
Bottom Line
View on ClinicalTrials.gov: NCT01075152 ↗Enrolled (actual)
177
Serious AEs
57.6%
Results posted
Aug 2014
Primary outcome: Primary: Mortality — 40; 27 participants — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- efavirenz (Drug); nucleoside (Biological)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality |
40; 27 | 0.03 sig |
| SECONDARY Incidence of Immune Reconstitution Inflammatory Syndrome |
17; 9 | 0.32 |
| SECONDARY Incidence of Cryptococcal-relapse |
2; 8 | 0.06 |
| SECONDARY Safety of ART Initiation |
73; 75 | 0.98 |
| SECONDARY 46-week Survival |
41; 29 | 0.04 sig |
| SECONDARY HIV-1 Viral Suppression |
43; 49 | 0.26 |
| SECONDARY Antiretroviral Therapy Tolerability |
5; 1 | 0.23 |
| SECONDARY Karnofsky Functional Status |
70; 70; 93; 93; 92; 95 | 0.34 |
| SECONDARY Microbiologic Clearance |
-0.31; -0.31; -0.39; -0.35 | 0.44 |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01075152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.