Could a simple antacid sabotage HIV treatment?
NCT ID NCT01784302
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This study asks whether common antacids or multivitamins change how the body absorbs raltegravir, an HIV medication. Healthy adult volunteers will take raltegravir alone and alongside different antacids or a multivitamin, with blood samples measuring drug levels over 12 hours. The goal is to see if these everyday products interfere with the drug, which could help optimize dosing for people living with HIV.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Raltegravir, an HIV medication, given with or without antacids (Maalox Plus, sodium bicarbonate) or multivitamins
- What this could lead to
- If it works, this could lead to better dosing guidance for people with HIV who need antacids or multivitamins, ensuring their medication works effectively.
- What could go wrong
- This is a small, early-stage study in healthy volunteers, not people with HIV. Results may not reflect real-world use, and the interaction may be minimal or vary by individual.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
15 people
The number who actually took part.
- Start date
-
Apr 2014
- Finished
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Feb 2016
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Royal Liverpool University Hospital
Liverpool, L7 8XP, United Kingdom
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