A Key Link for Transmission Prevention (MP3)

Inclusion Criteria:

Primary participants:

• Acute HIV-1 infection
• Men and women age greater than/= 18 years.
• Intention to remain in the Lilongwe area for the duration of the study.
• Ability and willingness of participant to provide informed consent.
• Willingness to provide contact/locator information, be contacted, and asked to return for AHI results.

Partner Participants:

• Referred by a primary participant and present with a referral card.
• Had vaginal or anal sex with a primary participant within 12 weeks prior to that primary participant's enrolling
• Men and women age greater than/=18 years.
• remain in the Lilongwe area for the duration of the study.
• Ability and willingness of participant to provide informed consent.

Exclusion Criteria:

Primary Participants:

• HIV infection based on two positive HIV antibody rapid tests at the time of screening.
• HIV-negative based on one or more antibody rapid test and an HIV RNA PCR test.
• Serious illness, including tuberculosis or opportunistic infection, requiring systemic treatment and/or hospitalization.
• Active drug or alcohol use or dependence.
• Current imprisonment or involuntary incarceration.
• Any other condition that in the opinion of the study investigator would compromise the safety of the study participant or study staff, or would prevent proper conduct of the study.

Partner Participants:

• Active drug or alcohol use or dependence.
• Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical illness.

Exclusion for Receipt of Antiretroviral Drugs in the BIA Arm

Note:A key component of this pilot study is to estimate the potential effect of ARVs during acute infection when applied on a large population scale.In effect, this pilot study should be viewed as a pilot for an effectiveness trial. Consequently, we will randomize all eligible participants to one of the three arms. If, however, persons should not receive ARVs for a variety of medically-related reasons, these persons will remain in the BIA arm, but will not receive ARVs. Women who are of reproductive potential but who refuse to use at least one form of contraception (see below), will remain in the BIA arm but will not receive ARVs. Similarly, persons randomized to the BI arm who do not attend all sessions will remain in the BI arm.

Persons randomized to BIA with any of the following conditions will be excluded from receiving ARVs, but will remain in the BIA group for purposes of analysis.

• Laboratory values obtained at Day 0 prior to initiating ARVs at a subsequent visit
• Absolute neutrophil count <300/mm3
• Hemoglobin <8.0 g/dL
• Platelet count <40,000/mm3
• Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase > 5 x upper limit of normal (ULN)
• Total bilirubin >2.5 x ULN
• Creatinine Clearance (CrCl) <60 mL/min
• Hepatitis B surface antigen positivity
• Positive serum or urine pregnancy test at Day 0.
• Breastfeeding
• Refusal to use at least one method of contraception, if a woman is of reproductive potential.

Acceptable forms of contraception include: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, intrauterine device (IUD), or a hormonal-based contraceptive.

Women not meeting the reproductive potential criteria above may receive the study drugs without using contraception.

• Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
• Requirement for any current medications that are prohibited with any study drugs.