A Two Way Cross Over Pharmacokinetic Interaction Study Between Raltegravir and Amlodipine in Healthy Volunteers
Condition: HIV
Intervention: Raltegravir; Amlodipine
Intervention description: Isentress 400mg tablet taken twice daily; generic amlodipine 5mg tablets (Accord healthcare Limited, UK)
Intervention MeSH terms: Raltegravir Potassium; Amlodipine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to look at the levels of an HIV medication (raltegravir) in the
      blood, and how it is affected if raltegravir is taken at the same time as another medicine
      for high blood pressure (amlodipine). Many patients with HIV will also have high blood
      pressure, so it is important to know which drugs for each of these conditions can be taken
      together without affecting how well they work individually.

      Over a 3 week period, participants took amlodipine for 2 weeks, and raltegravir for 2 weeks,
      with the middle week being on both drugs. The investigators will look at and compare the
      levels of these two drugs in the blood after subjects have taken them separately and both
      together.

      This study is randomised into two groups with both study medications received by all
      participants in a three-period crossover pattern; randomisation determined which medication
      was taken first. Once randomised allocation was performed, medications were administered in
      an open-label fashion.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must meet all of the following inclusion criteria within 28 days prior to the
        baseline visit:

          -  The ability to understand and sign a written informed consent form, prior to
             participation in any screening procedures and must be willing to comply with all study
             requirements

          -  Male or non-pregnant, non-lactating females

          -  Between 18 to 65 years, inclusive

          -  Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.

          -  Women of childbearing potential (WOCBP) must be using an adequate method of
             contraception to avoid pregnancy throughout the study and for a period of at least 12
             weeks after the study

          -  Willing to consent to their personal details being entered onto The Over-volunteering
             Prevention Scheme (TOPS) database

          -  Willing to provide photographic identification at each visit.

          -  Registered with a GP in the UK

        Exclusion Criteria:

        Subjects who meet any of the following exclusion criteria are not to be enrolled in this
        study.

          -  Any significant acute or chronic medical illness including hypertension (BP
             persistently >140/90 mmHg) or hypotension (BP persistently <90/60 mmHg)

          -  Evidence of organ dysfunction or any clinically significant deviation from normal in
             physical examination, vital signs, ECG or clinical laboratory determinations

          -  Positive blood screen for hepatitis B surface antigen and/or C antibodies

          -  Positive blood screen for HIV-1 and/or 2 antibodies

          -  Current or recent (within 3 months) gastrointestinal disease

          -  Clinically relevant alcohol or drug use (positive urine drug screen) or history of
             alcohol or drug use considered by the Investigator to be sufficient to hinder
             compliance with treatment, follow-up procedures or evaluation of adverse events.
             Smoking is permitted, but tobacco intake should remain consistent throughout the study

          -  Exposure to any investigational drug or placebo within 3 months of first dose of study
             drug

          -  Use of any other drugs (unless approved by the Investigator), including
             over-the-counter medications and herbal preparations, within two weeks prior to first
             dose of study drug, unless approved/prescribed by the Principal Investigator as known
             not to interact with study drugs.

          -  Females of childbearing potential without the use of effective non-hormonal birth
             control methods, or not willing to continue practising these birth control methods for
             at least 12 weeks after the end of the treatment period

          -  Previous allergy to any of the constituents of the pharmaceuticals administered in
             this trial

          -  Lactose intolerance