The Effect of Antacids and Multivitamins on Raltegravir
Phase 1
Completed
- Conditions
- HIV
- Interventions
- Drug: Maalox Plus extraDietary Supplement: MultivitaminsDietary Supplement: Sodium bicarbonate
- Registration Number
- NCT01784302
- Lead Sponsor
- Helen Reynolds
- Brief Summary
This study seeks to address the question of whether antacids or multivitamins influence the pharmacokinetics of raltegravir when co-administered. The aim of this study is to optimise the dosing of raltegravir when co-administered with antacids or multivitamins.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- 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.
- ≥ 18 years
- Male or female subjects
- A female may be eligible to enter and participate in the study if she:
- Is of non-child-bearing potential defined as ether post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age)or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or
- Is of child-bearing potential with a negative pregnancy test at screening and agrees to use one of the following methods of contraception to avoid pregnancy
- Complete abstinence from intercourse from 2 weeks prior to administration of IP, throughout the study and for at least 4 weeks after discontinuation of all study medication
- Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)
- Any intrauterine device (IUD) with published data showing that the expected failure rate is < 1 % per year
- Any other method with published data showing that the expected failure rate is < 1 % per year
- Hormonal contraception plus a barrier method. Hormonal contraception alone will not be considered adequate for inclusion into or participation in this study
- Male subjects with a female partner of childbearing potential must agree to use effective contraception as above unless vasectomized
- All subjects participating in the study will be counseled on safer sexual practices including the use of effective barrier methods (e.g. male condom)
Exclusion Criteria
- Any significant acute or chronic medical condition
- Pregnant or lactating women
- Women of childbearing age unless using non hormonal contraception
- Evidence of organ dysfunction or any clinically significant deviation from normal during screening including laboratory determinations
- Abnormal LFTs (ALT > 2.5 x ULN, bilirubin > 1.5 x ULN)
- Positive blood screen for HIV-1 and 2 antibodies
- Positive blood screen for hepatitis B or C antibodies
- Current or recent (within 3 months) gastrointestinal disease
- Clinically relevant alcohol or drug use or history of alcohol or drug use that will hinder compliance with treatment, follow up procedures or evaluation of adverse effects
- Use of proton pump inhibitors
- Exposure to any investigational drug or placebo within 4 weeks of first dose of study drug
- Consumption of grapefruit and oranges or products containing grapefruit or oranges within 1 week of first study drug and for the duration of the study
- Use of any other drugs including over-the-counter medications and herbal preparations, within 2 weeks prior to first dose of study drug
- Previous allergy to any of the constituents of the pharmaceuticals in this trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Maalox Plus extra Maalox Plus extra Subjects will receive doses of raltegravir 400 mg and maalox plus extra Multivitamin Multivitamins Subjects will receive doses of raltegravir 400 mg along with a multivitamin tablet Sodium bicarbonate Raltegravir 400 mg Subjects will receive doses of raltegravir 400 mg along with sodium bicarbonate Multivitamin Raltegravir 400 mg Subjects will receive doses of raltegravir 400 mg along with a multivitamin tablet Maalox Plus extra Raltegravir 400 mg Subjects will receive doses of raltegravir 400 mg and maalox plus extra Sodium bicarbonate Sodium bicarbonate Subjects will receive doses of raltegravir 400 mg along with sodium bicarbonate
- Primary Outcome Measures
Name Time Method Change in raltegravir Area under the curve (AUC)0-12h Day 1, 6, 11, 16 and 21 The primary endpoint will be a change in raltegravir AUC0-12 h, following dosing of antacid or multivitamin
- Secondary Outcome Measures
Name Time Method Measurement of gastrointestinal pH Day 1, 6, 11, 16 and 21 Correlation between gastric pH and raltegravir pharmacokinetics
Number of adverse events Day 1 up to end of study Day 27
Trial Locations
- Locations (1)
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom