Pharmacokinetics of Lopinavir/Ritonavir at Three Different Doses.
Condition: Acquired Immunodeficiency Syndrome
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: lopinavir/ritonavir
Intervention description: Each participant received three sequential doses of lopinavir/ritonavir: 400/100 mg twice daily (2 heat-stable 200/50 mg tablets BID), 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID), and 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period.
Intervention MeSH terms: Ritonavir; Lopinavir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV; ART; HAART; Pharmacokinetics; Lopinavir/ritonavir; Lower dose selection

Summary:

      The purpose of this study is to assess the pharmacokinetics of plasma lopinavir/ritonavir
      over a 12-hour dosing interval, following administration to male and female HIV-negative
      healthy volunteers of:

        1. Lopinavir/ritonavir 400/100 mg twice daily

        2. Lopinavir/ritonavir 200/150 mg twice daily

        3. Lopinavir/ritonavir 200/50 mg twice daily
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must meet all of the following inclusion criteria within 28 days prior to the
             baseline visit:

               1. 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

               2. Male or non-pregnant, non-lactating females

               3. Between 18 to 65 years, inclusive

               4. Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.

               5. 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 1 month after the study

        Exclusion Criteria:

          1. Any significant acute or chronic medical illness

          2. Evidence of organ dysfunction or any clinically significant deviation from normal in
             physical examination, vital signs, ECG or clinical laboratory determinations

          3. Positive blood screen for hepatitis B core and/or C antibodies and/or hepatitis B
             surface antigen

          4. Positive blood screen for HIV-1 and/or 2 antibodies

          5. Current or recent (within 3 months) gastrointestinal disease

          6. 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

          7. Exposure to any investigational drug or placebo within 3 months of first dose of study
             drug

          8. Consumption of grapefruit, or Seville oranges or any grapefruit or Seville orange
             containing product within one week of first dose of study drug and for the duration of
             the study

          9. Use of any other drugs, 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.

         10. 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 30 days after the end of the treatment period

         11. Previous allergy to any of the constituents of the pharmaceuticals administered in
             this trial