Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples
Brief Summary: This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.


Options:
A: Inclusion Criteria:

* 18 years of age or older
* Testing HIV positive at the largest-volume HIV point of testing (other than prevention of mother-to-child transmission or tuberculosis) at SU with written proof of test result
* Agreeing to be referred to the HIV care services associated with the SU
* Agreeing to provide locator information
* Agreeing to adhere to study procedures, including a baseline interview, interviews 1 and 12 months after study enrollment, and extraction of data from the HIV care and treatment electronic database
* Able to provide informed consent

Exclusion Criteria:

* Being pregnant at study enrollment
* Planning on leaving the community where they currently reside in the next 12 months
* Enrolled in HIV care in the past 6 months at any clinic
* Initiated ART (for any duration) in the past 6 months at any clinic
* Currently on ART
* Does not speak or understand Portuguese or Xitswa/Matswa
B: Inclusion Criteria for HIV Infected Partner:

* Positive HIV test within 60 days of study entry
* CD4 count between 350 and 550 cells/mm3 within 30 days of study entry
* If pregnant or breastfeeding, willing to be randomized to either arm of the study

Inclusion Criteria for HIV Uninfected Partner:

* Negative HIV test within 14 days of study entry

Inclusion Criteria for Both Partners:

* Plans to maintain sexual relationship with partner
* Reports having sex (vaginal or anal) with partner at least three times in the last 3 months
* Willing to disclose HIV test results to partner
* Plans to stay in the area and does not have a job or other obligations that may require long absences during the duration of the study

Exclusion Criteria for HIV Infected Partner:

* Current or previous use of any ART. Participants who previously took a short-term course of ART for prevention of mother-to-child transmission of HIV are not excluded.
* Documented or suspected acute hepatitis within 30 days of study entry, if the infected partner's starting regimen in the study contains nevirapine or atazanavir
* Current or previous AIDS-defining illness or opportunistic infection
* Documented or suspected acute hepatitis within 30 days prior to study entry
* Acute therapy of serious medical illnesses within 14 days prior to study entry
* Radiation therapy or systemic chemotherapy within 45 days prior to study entry
* Immunomodulatory or investigational therapy within 30 days prior to study entry
* Active drug or alcohol dependence that, in the opinion of the investigator, would interfere with the study
* Vomiting or inability to swallow medications
* Require certain medications
* Allergy or sensitivity to any of the study drugs

Exclusion Criteria for Both Partners:

* History of injection drug use within 5 years of study entry
* Previous and/or current participation in an HIV vaccine study
* Currently detained in jail or for treatment of a psychiatric or physical illness
* Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
* Certain abnormal laboratory values
C: 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.
D: Note: Participants who enrolled in this study prior to Version 3.0 will be offered and allowed to switch to FTC/TDF if they wish. However, participants under the age of 18 cannot receive FTC/TDF through this study.

Inclusion Criteria for Step 1:

* HIV-1 infected
* Currently being treated for OI (including Pneumocystis carinii pneumonia \[PCP\]; cryptococcal meningitis; disseminated histoplasmosis; disseminated Mycobacterium avium complex \[MAC\]; cytomegalovirus \[CMV\] retinitis; CMV encephalitis; toxoplasmic encephalitis; other atypical non-tuberculous, non-MAC mycobacterial infections; or other serious, invasive BIs). Participants who have tuberculosis (TB) alone are ineligible for this study. Participants with bacterial pneumonia or serious BI must have a CD4 count less than 200 cells/mm3 within 30 days prior to study entry. Participants with other serious OIs, including other AIDS-defining and -related OIs for which appropriate therapy other than ART exists are eligible, pending investigator approval. Participants' current OI treatment must have been started within 14 days prior to study entry, but may have been discontinued prior to study entry.
* Able to take oral medications
* Parent or guardian willing to provide informed consent, if applicable
* Willing to use acceptable methods of contraception

Exclusion Criteria for Step 1:

* Any ART within 8 weeks prior to study entry
* 31 or more days of any ARV within 6 months prior to entry
* History of more than one virologic, immunologic, or clinical treatment failure while on a HAART regimen, or a history of more than one regimen change for unknown reasons
* Systemic cancer chemotherapy within 30 days prior to study entry
* Immunomodulators within 30 days prior to study entry, including growth factors, immune globulin, interleukins, and interferons (unless for hepatitis C virus or Kaposi's sarcoma)
* Investigational ARV agents at study entry
* Systemic investigational agents (except ARV drugs) within 30 days prior to study entry will be allowed at the study official's discretion
* Anticipated use of certain medications
* Kidney failure requiring dialysis
* Current drug or alcohol use that, in the opinion of the study official, would interfere with the study
* Treatment for current, first-treated, and diagnosed OI or BI for more than 14 days prior to study entry
* Known resistance to ART that prohibits administration of an effective ART regimen
* Current OI has recurred within 90 days prior to study entry. Recurrent BIs are not excluded.
* Pregnant or breastfeeding

Answer: B