Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Control Trial of Early vs Delayed ART in the Treatment of Cryptococcal Meningitis.
Brief 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.


Options:
A: Inclusion Criteria:

* Age ≥18 years;
* Ability and willingness of participant to give written informed consent;
* CD4 cell count \</=500 cells/mm3
* WHO stage 1 or 2 disease as defined by the following conditions: Asymptomatic; Persistent generalized lymphadenopathy; Moderate unexplained weight loss (under 10% of presumed or measured body weight); Recurrent upper respiratory tract infections (sinusitis, tonsillitis, otitis media, pharyngitis); Herpes zoster; Angular cheilitis; Recurrent oral ulcerations; Papular pruritic eruptions; Seborrheic dermatitis; Fungal nail infections

Exclusion Criteria:

* Any use of ART in the past;
* Pregnancy or breastfeeding at the screening visit;
* Psychologically unprepared to start ART, based on ART readiness survey;
* Plans to transfer care to another clinic during the study period;
* WHO stage 3 or 4 disease.

Note: For the sub-study that includes patients with WHO stage 1 or 2 disease and CD4 count \>500, the inclusion and exclusion criteria are the same; only CD4 count is different.
B: Inclusion Criteria:

* HIV infection documented by a positive HIV antibody test at enrollment;
* Adult men and women (age\>18);
* Cryptococcal meningitis infection documented by a positive CSF CRAG or CSF identification of C. neoformans.
* Place of residence is located within a 50km radius of Harare.

Exclusion Criteria:

* Previous diagnosis (\>1 week) of and treatment for cryptococcal meningitis
* Currently on ARVs, or have been intermittently on and off ART in the past.
* Concurrent use of medications that affect the metabolism of fluconazole e.g., antiseizure medications, oral hypoglycaemic agents.
* History of cardiac failure and or predisposition to arrhythmias will be excluded.
* They are pregnant or active lactation women
* History of active hepatitis or hepatic or renal dysfunction will be excluded.
C: Inclusion Criteria:

* HIV-infected
* Received pre- and post-test counseling at the GHESKIO Centers
* CD4 count between 200 and 350 cells/mm3
* World Health Organization (WHO) Stage I, II, or III HIV disease
* Willing to use acceptable forms of contraception

Exclusion Criteria:

* WHO Stage IV HIV disease (AIDS)
* 7 or more days of cumulative ART prior to study entry OR on ART at time of study entry
* Active TB, if diagnostic work-up for TB is incomplete OR if decision to treat TB has not been made. More information on this criterion can be found in the protocol.
* Recurrent active TB OR history of interrupted or incomplete TB therapy. More information on this criterion can be found in the protocol.
* Has not been evaluated for latent TB and decision to treat latent TB with isoniazid has not been made. More information on this criterion can be found in the protocol.
* Requires ART in the next 3 months, in the opinion of the investigator
* Other serious medical illness requiring chronic maintenance therapy (e.g., hypertension, diabetes) UNLESS the individual has completed at least 14 days of therapy prior to study enrollment AND is clinically stable
* Any psychological condition (e.g., severe depression, schizophrenia) that, in the opinion of the investigator, may interfere with the study
* Any social condition (e.g., pending emigration, pending incarceration) that, in the opinion of the investigator, may interfere with the study
* Active drug or alcohol use that, in the opinion of the investigator, may interfere with the study
* Current inflammation of the pancreas
* Allergy/sensitivity to any of study drugs or their formulations
* Requires certain medications
* Enrolled in another therapeutic or interventional clinical trial
* Pregnant or breastfeeding
D: Inclusion Criteria:

* All MJAP-supported clinics in Kampala and Mbarara Districts

Exclusion Criteria:

* None.

Answer: B