A Two Year Study of the Clinical Efficacy of the Combination of Emtricitabine, Tenofovir, and Nevirapine
Condition: HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      Open label, two year study of the clinical efficacy of the combination of FTC, Tenofovir, and
      Nevirapine. Sixty HIV infected patients without previous exposure to antiretroviral therapy
      will be enrolled. Study will include a pharmacokinetic substudy to evaluate the interaction
      of FTC and Nevirapine. Truvada may be used.
    

Detailed description: 
      Description of study design This is an open-labeled clinical trial evaluating an
      antiretroviral treatment regimen in which the drugs have demonstrated in vitro activity in
      both, resting and activated mononuclear cells. These drugs include: FTC 200 mg p.o. qd, and
      Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d.

      Eligible patients must be at least 18 years of age, be referred by their primary HIV provider
      for antiretroviral therapy or if the patient is self referred, have a cluster of
      differentiation 4 (CD4) cell count of < 250/mm3 and have a viral load >5,000c/ml. Eligibility
      requirement for women is that they must have a CD4 cell count of <250 at the time of
      enrollment. This cutoff for women is based on unpublished data that there may be increased
      hepatotoxicity in women with a CD4 cell count > 250 cell/mm3. The screening evaluation will
      take place the day the informed consent is signed. During that screening evaluation, the
      patient will undergo a history and physical examination, and will have study labs drawn.
      Within 60 days of the screening evaluation and meeting all eligible criteria, the patient
      will be placed on the study treatment regimen. Patients will be evaluated at the clinic on
      Day 0 (therapy initiation), weeks 2, 4, 6, 8, 12, 16, and then every 8 weeks until 48 weeks
      and thereafter every 12 weeks through week 96. At the end of the study, all patients may
      continue their current antiretroviral treatment regimen at the discretion of the patient and
      their primary care provider.

      Pharmacokinetic Analysis Sub Study A pharmacokinetic evaluation will be performed in first 7
      volunteers to assess the impact of FTC on Nevirapine and vice versa. Pharmacokinetic analysis
      will be performed at end of week 2 ( day 14) during 200mg qd start up period. Samples will be
      obtained at baseline and 1, 3, 6, 12 and 24 hours post Nevirapine dosing. Pharmacokinetic
      analysis will be repeated at the week 8 visit. Samples will be obtained at baseline and 1, 3,
      6, 12 and 24 hours post Nevirapine.

      Assignment of patients There will be 60 patients involved in this clinical trial. This is an
      open-labeled study. There are no placebos involved in this study.

      Dose and dose selection The dosages of medications are those that are currently used as
      standard clinical practice: Nevirapine 200 mg b.i.d. (1-200 mg tablet b.i.d.); Emtricitabine
      (FTC) 200mg po qd.(1-200mg capsule); Tenofovir 300 mg once-a-day (1-300 mg tablet qd).

      Justification of study design All study patients require treatment for their HIV infection.
      All of the drugs used in this study are FDA-Approved. Tenofovir and FTC are approved as a
      once-a-day treatment medication. Nevirapine (NVP) is approved for BID dosing.

      NOTE: That whenever Nevirapine is being prescribed, there will be a lead-in period of 14 days
      in which Nevirapine will be prescribed as 200 mg once a day followed by 200 mg BID as is the
      recommended standard of care.
    

Intervention name(s): Nevirapine, FTC, and Tenofovir
Intervention type(s): Drug
Intervention description(s): One arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d.
Intervention MeSH terms: Tenofovir; Nevirapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment