HIVPhase 1NCT01784302
The Effect of Antacids and Multivitamins on Raltegravir
A Phase 1 study testing Multivitamins, Sodium bicarbonate and Maalox Plus extra in people with HIV, run by Helen Reynolds at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Multivitamins, Sodium bicarbonate and Maalox Plus extra
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Feb 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Liverpool University Hospital
Liverpool, L7 8XP
About this study
Official title: A 3 Arm, 5 Phase Study to Determine the Effect of Divalent and Monovalent Metal Containing Antacids and Multivitamins on the Pharmacokinetics of Raltegravir in Healthy Volunteers
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.
- Conditions
- HIV
- Being tested
- Multivitamins, Sodium bicarbonate, Maalox Plus extra, Raltegravir 400 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultivitaminsDietary supplement
Sodium bicarbonateDietary supplement
Maalox Plus extraDrug
Raltegravir 400 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir plus Maalox Plus | Active comparator | Subjects will be dosed with raltegravir 400 mg followed by raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus multivitamin (1 tablet), raltegravir plus sodium bicarbonate 1 g, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose on five separate days. Receives: Dietary Supplement: Multivitamins; Dietary Supplement: Sodium bicarbonate; Drug: Maalox Plus extra; Drug: Raltegravir 400 mg |
| Raltegravir plus Multivitamin | Active comparator | Subjects will be dosed with raltegravir 400 mg followed by raltegravir 400 mg plus multivitamin (1 tablet), raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose, raltegravir plus sodium bicarbonate 1 g on five separate days. Receives: Dietary Supplement: Multivitamins; Dietary Supplement: Sodium bicarbonate; Drug: Maalox Plus extra; Drug: Raltegravir 400 mg |
| Raltegravir plus Sodium bicarbonate | Active comparator | Subjects will be dosed with raltegravir 400 mg followed by raltegravir plus sodium bicarbonate 1 g, raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose, raltegravir 400 mg plus multivitamin (1 tablet), on five separate days. Receives: Dietary Supplement: Multivitamins; Dietary Supplement: Sodium bicarbonate; Drug: Maalox Plus extra; Drug: Raltegravir 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Raltegravir Area Under the Curve (AUC)0-12h
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.
Measured: Day 1, 6, 11, 16 and 21, over dosing period of 0-12 h
Secondary outcomes (2)
Measurement of Gastrointestinal pH
Correlation between gastric pH and raltegravir pharmacokinetics
Measured: Day 1, 6, 11, 16 and 21, four hours post dose
Number of Adverse Events
Number of adverse events reported from all arms of study including serious adverse events
Measured: Day 1 up to end of study Day 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startApr 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helen Reynolds
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Helen Reynolds, University of Liverpool
- Investigators
- Saye Khoo, Prof, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784302
- Sponsor's protocol ID
- 4347
- Status last verified
- Aug 2026
- First submitted
- 28 Jan 2013
- Last updated
- 17 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3 Arm, 5 Phase Study to Determine the Effect of Divalent and Monovalent Metal Containing Antacids and Multivitamins on the Pharmacokinetics of Raltegravir in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01784302
- Acronym / sponsor ID
- 4347
- Conditions
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Helen ReynoldsUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 Feb 2013 (estimated)
- Results
- Posted 17 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Raltegravir plus Maalox Plus | Active comparator | Dietary Supplement: Multivitamins, Dietary Supplement: Sodium bicarbonate, Drug: Maalox Plus extra, Drug: Raltegravir 400 mgSubjects will be dosed with raltegravir 400 mg followed by raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus multivitamin (1 tablet), raltegravir plus sodium bicarbonate 1 g, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose on five separate days. |
| Raltegravir plus Multivitamin | Active comparator | Dietary Supplement: Multivitamins, Dietary Supplement: Sodium bicarbonate, Drug: Maalox Plus extra, Drug: Raltegravir 400 mgSubjects will be dosed with raltegravir 400 mg followed by raltegravir 400 mg plus multivitamin (1 tablet), raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose, raltegravir plus sodium bicarbonate 1 g on five separate days. |
| Raltegravir plus Sodium bicarbonate | Active comparator | Dietary Supplement: Multivitamins, Dietary Supplement: Sodium bicarbonate, Drug: Maalox Plus extra, Drug: Raltegravir 400 mgSubjects will be dosed with raltegravir 400 mg followed by raltegravir plus sodium bicarbonate 1 g, raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose, raltegravir 400 mg plus multivitamin (1 tablet), on five separate days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multivitamins | Dietary supplement | Raltegravir plus Maalox Plus, Raltegravir plus Multivitamin, Raltegravir plus Sodium bicarbonate |
| Sodium bicarbonate | Dietary supplement | Raltegravir plus Maalox Plus, Raltegravir plus Multivitamin, Raltegravir plus Sodium bicarbonate |
| Maalox Plus extra | Drug | Raltegravir plus Maalox Plus, Raltegravir plus Multivitamin, Raltegravir plus Sodium bicarbonate |
| Raltegravir 400 mg | Drug | Raltegravir plus Maalox Plus, Raltegravir plus Multivitamin, Raltegravir plus Sodium bicarbonate |
Primary outcome
Change in Raltegravir Area Under the Curve (AUC)0-12h
Time frame: 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.
2 secondary outcomes
Measurement of Gastrointestinal pH
Time frame: Day 1, 6, 11, 16 and 21, four hours post dose
Number of Adverse Events
Time frame: Day 1 up to end of study Day 27
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saye Khoo, Prof principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Multivitamins, Sodium bicarbonate and Maalox Plus extra in people with HIV, run by Helen Reynolds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Raltegravir Area Under the Curve (AUC)0-12h (time frame: Day 1, 6, 11, 16 and 21, over dosing period of 0-12 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.