A Two Year Study of the Clinical Efficacy of the Combination of Emtricitabine, Tenofovir, and Nevirapine

Inclusion Criteria

• HIV-1 infection, as documented by any licensed ELISA test kit, and confirmed by Western blot, positive HIV-1 blood culture, positive HIV serum antigen, or plasma viremia at any time prior to study entry. If no record exists, testing must occur at screening.
• Male or female, age 18 to 75 years of age.
• Able to sign the informed consent, and is willing to comply with the requirements of this clinical trial.
• Available for at least 96 weeks of follow up.
• Males: deemed a candidate for antiretroviral therapy per referring primary care provider. (If patient is self referred, CD4 cell count must be 5,000c/ml) Females: CD4 cell count must be less than 250 cells/mm3 and viral load >5,000 c/mL at time of enrollment.
• If female and of child bearing potential must consent to using at least two forms of contraception.
• Participants will be "treatment naive" as no prior antiretroviral therapy or antiretroviral therapy for less than 7 days in the past.

Exclusion Criteria

• Evidence of mutation associated with primary drug resistance to Nevirapine (K103N, Y181C, Y188L, G190S), Tenofovir (M41L, T69 insertion, Q151M, L210W,and K65R), and/or FTC (184V) previously documented, or at time of screening.
• Patients with any of the following laboratory parameters at the screening visit: estimated creatinine clearance of 2.5 times the upper limits of normal; total bilirubin >1.5 mg/dL.
• Women with CD4 cell count > 250 cells/ mm3 at time of entry or in males with a CD4 cell count less than 400/mm3, along with a viral load greater than 5,000c/ml. for both males and females.
• Pregnant women or women who are breast feeding.
• Unwillingness to use effective barrier contraception.
• Patients with current alcohol abuse or illicit drug use that in the opinion of the Principal Investigator may interfere with the patient's ability to comply with the protocol requirements.
• Patients with malabsorption or severe chronic diarrhea for more than 30 days.
• Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• History of any chronic illness or other condition that in the opinion of the investigator would interfere with the conduct or completion of the study.
• Patient who is, in the opinion of the investigator, unable to complete the 96-week dosing period and protocol evaluations and assessments.
• Experimental vaccines, to include HIV vaccines.
• Patient who is currently enrolled in an experimental protocol, or is receiving an experimental medication.