HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine
Condition: Acute HIV Infection; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Viremia
Intervention: Darunavir; Ritonavir; Etravirine
Intervention description: 800 mg orally once daily; 100 mg orally once daily; 200 mg orally twice daily, although patients may choose to take ETR 400 mg QD to have a simpler all QD regimen
Intervention MeSH terms: Ritonavir; Darunavir; Etravirine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute HIV; HIV; Treatment Naive; Acute Infections

Summary:

      Purpose: This is a pilot study to evaluate HIV viremia and persistence in acutely HIV
      infected antiretroviral naïve patients treated with Darunavir/ritonavir and Etravirine

      Participants: 20 participants, age 18 and older, HIV infected, antiretroviral naïve patients

      Procedures (methods): ARV treatment with Darunavir/ritonavir and Etravirine,

      Optional studies:

      Genital secretion samples, Cerebrospinal fluid samples, Leukapheresis, Endoscopy/colonoscopy
    

Eligibility criteria:

        Inclusion Criteria:

          1. Documentation of Acute HIV Infection as defined above.

          2. Men and women age ≥18 years.

          3. Participants will be ART naïve, defined as ≤14 days of antiretroviral treatment at any
             time prior to entry. The only exceptions are: Post-exposure prophylaxis (PEP) provided
             the patient was documented as HIV-1 negative at least 3-6 months after completion of
             the PEP treatment.

          4. Screening HIV-1 RNA >1,000 copies/mL obtained within 30 days at study entry.

          5. Lab values obtained within 30 days prior to study entry:

          6. Absolute neutrophil count >500/mm3

          7. Hemoglobin > 8.5 g/dL for men and > 8.0 g/dL for women

          8. Platelet count >50,000/mm3

          9. AST (SGOT) ≤2.5 x ULN

         10. ALT (SGPT) ≤2.5 x ULN

         11. Total bilirubin <2.5 x ULN

         12. Calculated creatinine clearance (Cockcroft-Gault formula) > 30mL/min:

               -  CrCl = (140-age) x body weight (kg) (x 0.85 if female)

               -  Serum creatinine [mg/dL] x (72)

         13. For women of reproductive potential, a negative serum or urine pregnancy test within 7
             days 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 (e.g.,
             hysterectomy, bilateral oophorectomy, or salpingotomy). Acceptable documentation of
             surgical sterilization includes patient-reported history.

         14. If participating in sexual activity that could lead to pregnancy, female study
             patients must use at least one form of contraception, which could consist only of a
             barrier method. All patients must continue to use contraception for 6 weeks after
             stopping the study medications. Acceptable methods of contraception include: condoms
             (male or female) with or without spermicidal agent, diaphragm or cervical cap with
             spermicide, or IUD. Female volunteers not of reproductive potential are not required
             to use contraception.

         15. Ability and willingness of patient to give written informed consent.

        Exclusion Criteria:

          1. Women who are pregnant or breast-feeding.

          2. Women with a positive pregnancy test on enrollment or prior to study drug
             administration.

          3. Women of reproductive potential who are unwilling or unable to use acceptable methods
             to avoid pregnancy for the entire study period

          4. Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine,
             systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to
             study entry.

               -  Prednisone at a daily dose of 10 mg or less (physiologic replacement dose) is
                  permitted.

          5. Known allergy/sensitivity to study drugs or their formulations.

          6. Difficulty swallowing capsules/tablets.

          7. Inability to communicate effectively with study personnel.

          8. Incarceration; prisoner recruitment and participation are not permitted.

          9. Active drug or alcohol use or dependence that, in the opinion of the site
             investigator, would interfere with adherence to study requirements or confound the
             analysis of study endpoints.

         10. Any active psychiatric illness including schizophrenia, severe depression, or severe
             bipolar affective disorder that, in the opinion of the investigator, could confound
             the analysis of the neurological examination or neuropsychological test results.

         11. Active brain infection (except for HIV-1), brain neoplasm, space-occupying brain
             lesion requiring acute or chronic therapy. Participants with any fungal meningitis,
             parasitic infection, or CNS lymphoma are excluded from participation.

         12. Serious illness requiring systemic treatment and/or hospitalization until patient
             either completes therapy or is clinically stable on therapy, in the opinion of the
             site investigator, for at least 7 days prior to study entry. NOTE: Oral candidiasis,
             vaginal candidiasis, mucocutaneous herpes simplex, and other minor illnesses (as
             judged by the site investigator) have no restriction.

         13. Known cardiac conduction disease.

         14. Prior treatment with any other experimental drug for any indication (within 30 days of
             initiating study treatment).

         15. Unable to discontinue any current medications that are excluded during study
             treatment.

         16. A life expectancy less than twelve months.

         17. Acute Viral Hepatitis, including, but not limited to, Hepatitis A, B, or C

         18. Chronic Hepatitis B Infection documented by a detectable serum Hepatitis B surface
             antigen (HBsAg) or plasma HBV DNA