Phase 1
N=22
Pharmacokinetics of Lopinavir/Ritonavir at Three Different Doses.
Acquired Immunodeficiency Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00985543 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Plasma Lopinavir/Ritonavir Concentrations as Measured by the Area Under the Curve (AUC 0-12h). — 99599; 73603; 45146 ng.h/mL — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- lopinavir/ritonavir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kirby Institute
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Lopinavir/Ritonavir Concentrations as Measured by the Area Under the Curve (AUC 0-12h). |
99599; 73603; 45146 | <0.05 sig |
| SECONDARY Adverse Events |
27; 2; 4 | — |
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:
- 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 1 month after the study
Exclusion Criteria
- Any significant acute or chronic medical illness
- 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 core and/or C antibodies and/or hepatitis B surface antigen
- 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
- 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
- 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.
- 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
- Previous allergy to any of the constituents of the pharmaceuticals administered in this trial
Data sourced from ClinicalTrials.gov (NCT00985543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.