Treatment of Acute HIV Infection With Quad Fixed-dose Combination (FDC) Tablet

Inclusion Criteria

• •Acute HIV infection is defined as:
• •1. A positive 4th generation HIV Ag/Ab Combination Assay and HIV RNA (NAAT or viral load) and one of the following within 30 days of study entry:
• •* a negative HIV rapid test
• •* negative/indeterminate Western Blot
• •OR
• •2. A negative or indeterminate HIV antibody, antigen, or nucleic acid amplification test (NAAT) and any one of the following within 30 days of study entry:
• •* A detectable HIV nucleic acid in blood confirmed by a second NAAT
• •* Positive p24 antigen
• •* A positive HIV antibody test according to standard criteria obtained within 45 days after an initial negative or indeterminate HIV antibody, antigen, or nucleic acid amplification.
• •1. Acute HIV Infection (as defined above) within 30 days of study entry.
• •2. Age \>18 years.
• •3. ART-naive (\<14 days of previous antiretroviral treatment. Exceptions are: Post-exposure prophylaxis (PEP) if participant was documented as HIV-negative at least 3 months after completion of PEP.
• •4. Lab values within 30 days prior to study entry:
• •1. Absolute neutrophil count \>500/mm3
• •2. Hemoglobin \> 8.5 g/dL for men and \> 8.0 g/dL for women
• •3. Platelet count \>50,000/mm3
• •4. AST (SGOT)\> .2.5 x ULN
• •5. ALT (SGPT)\> .2.5 x ULN
• •6. Total bilirubin \<2.5 x ULN
• •7. Calculated creatinine clearance (Cockcroft-Gault formula) \> 70mL/min:
• •5. For women of reproductive potential, a negative pregnancy test within 72 hours prior to initiating antiretroviral study medications. Reproductive potential is defined as females who have reached menarche and have not been post-menopausal for at least 24 consecutive months, or have not undergone surgical sterilization.
• •6. Female study participants must use a reliable form of barrier contraception, such as a condom, even if they also use other methods of birth control. All participants must continue to use contraception for 12 weeks after stopping study medications. Acceptable methods of barrier contraception include: condoms (male or female), diaphragm, or cervical cap. These can be used alone or in tandem with hormonal or IUD method.
• •7. Ability and willingness of participant to give written informed consent.