HIV
Conditions
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.
Interventions
Sponsors
Helen Reynolds
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Raltegravir Area Under the Curve (AUC)0-12h | Day 1, 6, 11, 16 and 21, over dosing period of 0-12 h | The primary endpoint will be a change in raltegravir AUC0-12 h, following dosing of antacid or multivitamin. Data collected at the following time points: pre dose, 1, 2, 3, 4, 6, 8 10 and 12 h post dose on Days 1, 6, 11, 16 and 21. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Gastrointestinal pH | Day 1, 6, 11, 16 and 21, four hours post dose | Correlation between gastric pH and raltegravir pharmacokinetics |
| Number of Adverse Events | Day 1 up to end of study Day 27 | Number of adverse events reported from all arms of study including serious adverse events |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORSaye Khoo, Prof
University of Liverpool
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 32 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United Kingdom | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 10 | 0 / 11 | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 10 / 14 | 3 / 10 | 2 / 11 | 3 / 11 | 5 / 10 |
| serious Total, serious adverse events | 0 / 14 | 0 / 10 | 1 / 11 | 0 / 11 | 0 / 10 |
Outcome results
None listed