HIV InfectionsPhase 1NCT00944307
Effect of Antacids on the Pharmacokinetics of Raltegravir
A Phase 1 study testing raltegravir and antacid in people with HIV Infections, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to test whether there is a drug interaction between raltegravir (a medicine used to treat the human immunodeficiency virus or HIV) and antacids. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- raltegravir and antacid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Absence of HIV-1 infection as documented by any licensed ELISA test kit within 21 days prior to study entry.
- Age greater than or equal to 18 but less than or equal to 60 years.
- Ability and willingness to give written informed consent.
- Within 30% (+/-) of ideal body weight and total body weight of ≥ 50 kg.
- Hematology, Metabolic Profile, Renal, and Hepatic Function tests all within normal limits.
- Creatine kinase (CK) less than 3 times the upper limit of normal
Who cannot join
- Pregnancy or breast-feeding.
- Women and men of reproductive potential who are actively engaging in sexual activity or assisted reproductive technology with the intent of pregnancy.
- Allergy/sensitivity to raltegravir.
- Allergy/sensitivity to antacids.
- Active drug or alcohol abuse or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. While on study, subjects will be instructed not to consume alcohol for 48 hours prior the screening visit, and for the 24 hours preceding the intensive pharmacokinetic (PK) study visits and for 24 hours following the completion of the study visits.
- Any medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate in this protocol.
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- Participation in any investigational drug studies within 30 days prior to study entry.
- History of or active cardiovascular, renal, hematologic, hepatic, neurologic, gastrointestinal, psychiatric, endocrine, or immunologic disease(s). This is inclusive of chronic illnesses such as hypertension, coronary artery disease, arthritis, diabetes, any chronic gastrointestinal conditions that might interfere with drug absorption.
- Use of investigational, prescription, and over-the-counter medications within 14 days of study entry with the following exceptions: aspirin, acetaminophen, ibuprofen, and oral contraceptives
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Effect of Antacids on the Pharmacokinetics of Raltegravir in Healthy Volunteers
The purpose of this study is to test whether there is a drug interaction between raltegravir (a medicine used to treat the human immunodeficiency virus or HIV) and antacids.
Read the detailed description
This study will determine if an interaction occurs between the HIV medicine raltegravir and an antacid. A prior study found an interaction with another medicine like raltegravir called elvitegravir and an antacid. The elvitegravir levels were reduced by half. The same interaction may occur with raltegravir and an antacid based on the structure of this medicine and how it works. When the levels of HIV medications are reduced, people with HIV can "fail" their treatment. The virus can multiply when the drug levels are too low and the medications can stop working. We need to be sure that antacids will not cause this problem with raltegravir.
- Conditions
- HIV Infections
- Being tested
- raltegravir, antacid
- Keywords
- HIV, antiretroviral, drug interaction, human immunodeficiency virus
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
raltegravirDrug
Also called Isentress
raltegravir 400mg orally once
antacidDrug
Also called Isentress, Maalox Plus Extra Strength
aluminum, magnesium, simethicone-containing antacid 30mL orally once
| Study group | Role | What they receive |
|---|---|---|
| raltegravir alone | Active comparator | Subjects will receive a single dose of 400 mg raltegravir orally Receives: Drug: raltegravir |
| raltegravir plus antacid | Experimental | Subjects will receive a single dose of 400mg raltegravir orally simultaneously with an antacid Receives: Drug: raltegravir; Drug: antacid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raltegravir AUC with and without an antacid
Measured: 0-48 hours
Secondary outcomes (1)
Raltegravir Cmax with and without an antacid
Measured: 0-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer J Kiser, PharmD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944307
- Sponsor's protocol ID
- 09-0475
- Status last verified
- Jun 2017
- First submitted
- 20 Jul 2009
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antacids on the Pharmacokinetics of Raltegravir in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00944307
- Acronym / sponsor ID
- 09-0475
- Conditions
- HIV Infections
- Keywords
- HIV, antiretroviral, drug interaction, human immunodeficiency virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether there is a drug interaction between raltegravir (a medicine used to treat the human immunodeficiency virus or HIV) and antacids.
Detailed description
This study will determine if an interaction occurs between the HIV medicine raltegravir and an antacid. A prior study found an interaction with another medicine like raltegravir called elvitegravir and an antacid. The elvitegravir levels were reduced by half. The same interaction may occur with raltegravir and an antacid based on the structure of this medicine and how it works. When the levels of HIV medications are reduced, people with HIV can "fail" their treatment. The virus can multiply when the drug levels are too low and the medications can stop working. We need to be sure that antacids will not cause this problem with raltegravir.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| raltegravir alone | Active comparator | Drug: raltegravirSubjects will receive a single dose of 400 mg raltegravir orally |
| raltegravir plus antacid | Experimental | Drug: raltegravir, Drug: antacidSubjects will receive a single dose of 400mg raltegravir orally simultaneously with an antacid |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Absence of HIV-1 infection as documented by any licensed ELISA test kit within 21 days prior to study entry.
- Age greater than or equal to 18 but less than or equal to 60 years.
- Ability and willingness to give written informed consent.
- Within 30% (+/-) of ideal body weight and total body weight of ≥ 50 kg.
- Hematology, Metabolic Profile, Renal, and Hepatic Function tests all within normal limits.
Key exclusion criteria (9 listed)
- Pregnancy or breast-feeding.
- Women and men of reproductive potential who are actively engaging in sexual activity or assisted reproductive technology with the intent of pregnancy.
- Allergy/sensitivity to raltegravir.
- Allergy/sensitivity to antacids.
- Active drug or alcohol abuse or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. While on study, subjects will be instructed not to consume alcohol for 48 hours prior the screening visit, and for the 24 hours preceding the intensive pharmacokinetic (PK) study visits and for 24 hours following the completion of the study visits.
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 |
|---|---|---|
| raltegravirAlso: Isentressraltegravir 400mg orally once | Drug | raltegravir alone, raltegravir plus antacid |
| antacidAlso: Isentress, Maalox Plus Extra Strengthaluminum, magnesium, simethicone-containing antacid 30mL orally once | Drug | raltegravir plus antacid |
Primary outcome
Raltegravir AUC with and without an antacid
Time frame: 0-48 hours
1 secondary outcome
Raltegravir Cmax with and without an antacid
Time frame: 0-48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
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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.
Jennifer J Kiser, PharmD principal investigator
University of Colorado, Denver
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 raltegravir and antacid in people with HIV Infections, run by University of Colorado, Denver at 1 site in United States.
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 6 inclusion and 9 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 28 Jun 2017. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Raltegravir AUC with and without an antacid (time frame: 0-48 hours). 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 28 Jun 2017.