• INCLUSION CRITERIA:

  1. For the National Institutes of Health (NIH)/US site: HIV-1 infection, as documented by OraQuick rapid test using venipuncture whole blood, or fingerstick whole blood done at screening; or by reactive enzyme-linked immunosorbent assay (ELISA) and Western Blot as determined by NIH Clinical Pathology Laboratory" or SAIC-Frederick Inc Monitoring Laboratory. HIV infection as determined by an outside Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory facility" will be accepted for enrollment and verified by a standard HIV-1 ELISA with Western Blot at NIH.

     For Keny Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP CRC)/Kenya site: HIV-1 infection will initially be diagnosed based upon two, serial rapid HIV tests according to Kenya Ministry of Health (MOH) guidelines. Volunteers entering this study will have HIV infection confirmed by two serial rapid HIV test in accordance with Kenya MOH guidelines and testing algorithm followed by a confirmation with a Western Blot using FDA approved-kits. Samples from participants with discrepant results (between the results from other institution and KEMRI/WRP-CRC laboratory) and/or indeterminate/negative Western Blot will be subjected to a nucleic acid assay i.e. DNA or RNA PCR.

  2. No previous treatment with potent combination anti-retroviral therapy (ART), defined as any protease inhibitor (PI)-based or non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen, or even triple nucleoside reverse transcriptase inhibitors (NRTI)-based regimen, consisting of at least three antiretroviral drugs (including a boosted PI with NNRTI combination). Patients with limited use of ART (less than 12 weeks duration) more than 24 weeks before screening will be eligible for study participation.
  3. Screening CD4+ cell count less than or equal to 100 cells/mm(3). * Note: CD4 < 100 cells/microL from an outside or the site's laboratory within 8 weeks prior to screening can be accepted as the screening value.
  4. Residence within the wider Washington D.C. area (approximately within a 120-mile radius from the NIH Bethesda campus) for the national Institutes of Health/US site and residents of the Kericho District Hospital catchment area, an approximate 93-mile (150 kilometers0 radius, for the KEMRI/WRP CRC/Kenya site.
  5. Men and women age greater than or equal to 18 years.
  6. Ability and willingness of subject or legal guardian/representative to understand study requirements and give informed consent.
  7. Be willing to allow storage of blood or tissue samples for future research.
  8. Be willing to have HLA testing.
  9. For the NIH/US site: Participants must have primary care physician or will need to agree to find one during the first 24 weeks on study. For the KEMRI/WRP/Kenya site: Participants must be enrolled in the Kericho District Hospital HIV Clinic.

EXCLUSION CRITERIA:

1. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
2. Pregnancy will be an exclusion criterion for study entry given the intense nature of the protocol regarding blood draws, diagnostic testing, and follow-up.