Healthy VolunteersPhase 1RALMET-VOLHCBNCT00772720
Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers
A Phase 1 study testing raltegravir in people with Healthy Volunteers, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Raltegravir is the first of a new antiretroviral class. A better profile of metabolic toxicity is expected. In order to better define its effects, without interference with other drugs, a study on healthy volunteers is warranted. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- raltegravir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2010to Mar 2011
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male.
- age between 18 and 45.
- BMI between 19 and 25 kg/m2
- Normal physical exam.
- Blood analysis without relevant findings.
- Negative serology for hepatitis B, Hepatitis C and HIV.
- Negative urine test for abuse drugs.
Who cannot join
- Severe psychiatric disease.
- Dyslipemia.
- Alcohol intake above 30 g per day.
- Smokers
- Xanthine intake above 5 coffee cup -equivalents per day
- Use of any drugs in the last month
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- Participation in other trials in the last 3 months
- Diseases capable to modify drug ADME
- Drug allergy
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic
Barcelona, Catalonia, 08036
Esteban Martinez, MD, 0034932275400 ext. 3310, esteban@fundsoriano.es
About this study
Official title: Study on the Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers
Raltegravir is the first of a new antiretroviral class. A better profile of metabolic toxicity is expected. In order to better define its effects, without interference with other drugs, a study on healthy volunteers is warranted.
- Conditions
- Healthy Volunteers
- Being tested
- raltegravir, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
raltegravirDrug
Also called Isentress
raltegravir 400 mg BID for 7 days
PlaceboDrug
Placebo BID for 7 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of total cholesterol
Measured: 7 days
Secondary outcomes (3)
Changes in HDL, LDL and triglycerides
Measured: 7 days
Oral glucose tolerance test
Measured: 7 days
Mitochondrial DNA levels
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startMar 2010
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772720
- Sponsor's protocol ID
- RALMET-VOLHCB
- Other IDs
- EUDRACT #: 2008- 003288-37
- Acronym
- RALMET-VOLHCB
- Status last verified
- Mar 2010
- First submitted
- 14 Oct 2008
- Last updated
- 31 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00772720
- Acronym / sponsor ID
- RALMET-VOLHCB / RALMET-VOLHCB
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 15 Oct 2008 (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.
Raltegravir is the first of a new antiretroviral class. A better profile of metabolic toxicity is expected. In order to better define its effects, without interference with other drugs, a study on healthy volunteers is warranted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male.
- age between 18 and 45.
- BMI between 19 and 25 kg/m2
- Normal physical exam.
- Blood analysis without relevant findings.
Key exclusion criteria (9 listed)
- Severe psychiatric disease.
- Dyslipemia.
- Alcohol intake above 30 g per day.
- Smokers
- Xanthine intake above 5 coffee cup -equivalents per day
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 400 mg BID for 7 days | Drug | – |
| PlaceboPlacebo BID for 7 days | Drug | – |
Primary outcome
Blood levels of total cholesterol
Time frame: 7 days
3 secondary outcomes
Changes in HDL, LDL and triglycerides
Time frame: 7 days
Oral glucose tolerance test
Time frame: 7 days
Mitochondrial DNA levels
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2010.
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Screening Protocol
Pain
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.
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 in people with Healthy Volunteers, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 7 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: status not confirmed, as of the sponsor's last update on 31 Mar 2010. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood levels of total cholesterol (time frame: 7 days). 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 31 Mar 2010.