Treatment of Acute HIV With Emtricitabine, Tenofovir and Efavirenz (CID 0805)
Condition: Acute HIV Infection; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: efavirenz, emtricitabine, and tenofovir
Intervention description: Once daily ART with emtricitabine, tenofovir DF and efavirenz
Intervention MeSH terms: Tenofovir; Emtricitabine; Efavirenz
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute HIV; HIV; Acute Infections; Acute Infection

Summary:

      This is a pilot study of treatment of acute HIV infection with a once daily regimen of
      Emtricitabine, Tenofovir and Efavirenz. The primary objectives of this study are:

        1. To determine the safety and tolerability, and the virologic and immunologic efficacy of
           FTC, TDF, and efavirenz given once daily to patients with acute HIV infection.

        2. To assess the impact of once daily therapy combined with a standardized adherence
           program on treatment adherence, virologic suppression, and rate of viral load decline in
           blood and infectious fluids (semen, cervico-vaginal secretions).

        3. To define the prevalence of genotypic and phenotypic resistance to antiretroviral agents
           among persons diagnosed with acute HIV infection in the Southeastern United States.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of acute HIV infection as defined by protocol.

          2. The following laboratory parameters verified within 30 days of study entry:

               -  Bilirubin </= 3.0mg/dL

               -  ALT/AST </= 10 X upper limit of normal

               -  Absolute neutrophil count (ANC) >/= 500cells/mm3

               -  Platelet count >/= 25,000 cells/mm3

               -  Hemoglobin >/= 8.5g/dL for men and >/= 8.0 g/dL for women

               -  Calculated creatinine clearance (Cockcroft-Gault formula) >/= 50mL/min:

             CrCl = (140-age) x body weight (kg) (x 0.85 if female)/ Serum creatinine [mg/dL] x
             (72)

          3. All women of child-bearing potential (WOCBP) must have a negative serum or urine
             pregnancy test (minimum sensitivity 25 IU/L or equivalent units of bHCG) within 72
             hours prior to start of study medication. WOCBP is defined as any female who has
             experienced menarche and who has not undergone successful surgical sterilization
             (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), who is not
             postmenopausal (defined as amenorrhea >/=12 consecutive months), or is on hormone
             replacement therapy (HRT) with documented plasma follicle-stimulating hormone level
             >/=35mLU/mL. Women who are using oral, implanted, or injectable contraceptive hormones
             or mechanical products such as an intrauterine device or barrier methods (diaphragm,
             condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner
             is sterile (e.g., vasectomy), should be considered to be of child bearing potential;

          4. Be willing to use two effective forms of contraception throughout study. Barrier
             contraception should always be used in combination with other methods of contraception
             (oral or other hormonal contraceptives);

          5. Weigh >/= 40 kg;

        Exclusion Criteria:

          1. A life expectancy less than twelve months.

          2. Women who are pregnant or breastfeeding.

          3. Women with a positive pregnancy test on enrollment or prior to study drug
             administration.

          4. WOCBP who are unwilling or unable to use two acceptable methods to avoid pregnancy for
             the entire study period

          5. WOCBP using a prohibited contraceptive method

          6. Hypersensitivity to any component of the formulation of study drugs.

          7. A clinically important illness not explicitly excluded by the protocol, a physical or
             psychiatric disability, or a laboratory abnormality that might place the patient at
             increased risk by being exposed to the medications in this study or which might
             confound the interpretation of this investigation.

          8. Proven or suspected acute hepatitis within 30 days prior to study entry (this excludes
             liver inflammation related to acute HIV infection).

          9. Intractable diarrhea (>/=6 loose stools/day for at least 7 consecutive days) within 30
             days prior to study entry or vomiting lasting more than 4 days within one month prior
             to dosing (this excludes symptoms attributed to acute HIV infection).

         10. An active AIDS-defining opportunistic infection or disease (for the purpose of this
             study, a CD4 count </=200 cells/mm3 in the absence of any other AIDS-defining
             indicator condition is not considered an AIDS-defining event. AIDS-defining events
             occurring during the acute HIV infection syndrome period such as Candida esophagitis
             will be considered on a case-by-case basis and will not be automatically considered
             exclusionary).

         11. Inability to communicate effectively with study personnel.

         12. Current alcohol or recreational drug use which in the investigator's opinion
             interferes with the subject's ability to comply with dosing schedule and protocol
             evaluations or increases the risk of developing pancreatitis.

         13. Incarceration; prisoner recruitment and participation are not permitted.

         14. Difficulty swallowing capsules/tablets.

         15. Prior treatment with any other experimental drug for any indication (within 30 days of
             initiating study treatment).

         16. Treatment with immune-modulating agents (within 30 days of initiating study treatment)
             such as cyclosporine and systemic corticosteroids. Routine vaccinations are allowed.

         17. Therapy with agents with significant systemic neurotoxic pancreotropic or cytotoxic
             potential within 3 months of study start, or the need for such therapy is expected at
             the time of enrollment.

         18. Therapy with nephrotoxic agents (aminoglycosides, IV amphotericin, cidofovir, IV
             pentamidine, cisplatin other agents with nephrotoxic potential), adefovir or
             probenecid. These agents must be discontinued at least 30 days prior to starting study
             medications. Brief course of aminoglycosides within 30 days of enrollment may be
             allowed after discussion with Study Chairs.

         19. Concomitant Medications:

               -  The following medications are expressly prohibited during the course of the
                  trial: Astemizole, cisapride, ergot derivatives, hydroxyurea, midazolam,
                  thalidomide, triazolam, vincristine, zalcitabine, ribavirin, doxorubicin,
                  Voriconazole, St. John's wort or any medications that are contraindicated for
                  concomitant use as described in the current product information packet insert for
                  the ARV therapies used.