HIV InfectionsNCT00745368
Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women
A study testing Raltegravir in people with HIV Infections, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Raltegravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jun 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documentation of blood seropositive for HIV based on self report and confirmed by ELISA and Western blot or detectable HIV RNA
- Stable anti-retroviral regimen for at least 3 weeks prior to enrollment
- Capable of giving informed consent
- Age 18 years and older
Who cannot join
- Neoplasms
- Women who are pregnant or nursing
- History or current evidence of any significant acute or chronic medical illness that in the opinion of the investigator would preclude the subject from safely participating in the study
- Current use of phenobarbital, phenytoin, or rifampin
- Any major surgery within 4 weeks of enrollment
- Blood transfusion within 4 weeks of enrollment
Show all 12Show fewer
- Inability to tolerate oral medication
- Inability to tolerate venipuncture, venous access, or genital tract sampling
- History of recent (within 6 months) drug or alcohol abuse
- Evidence of organ dysfunction or any clinically significant deviation from normal in the medical history, physical examination, vital signs, and or clinical laboratory determinations that in the opinion of the investigator would preclude the subject from safely participating in the study
- Any other sound medical, psychiatric and or social reason for exclusion as determined by the investigator
- History of allergy to study medication or related compounds
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.
Read the detailed description
Although we have many medications to fight the HIV virus, very little is known about how much of these medications get into the genital tract. Raltegravir is a new HIV medication that blocks HIV growth and lowers the amount of virus in the blood in a way that is different than all other currently available HIV medications. Raltegravir was recently approved by the Food and Drug Administration (FDA) for use in HIV infected patients, but there is very little information concerning how much raltegravir will reach the genital tract of men or women. The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.
- Conditions
- HIV Infections
- Being tested
- Raltegravir
- Keywords
- HIV, Raltegravir, pharmacokinetics, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
400 mg tablets twice daily during duration of trial
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir | Experimental | Raltegravir 400 mg tablets twice daily Receives: Drug: Raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raltegravir Male Genital Tract Concentration
Measured: 8-10 hours after raltegravir dose
Raltegravir Female Genital Tract Concentration
Measured: 8-10 hours after raltegravir dose
Male Paired Plasma Concentration
This sample was taken as close to the time of genital tract sample as possible
Measured: 8-10 hours after raltegravir dose
Female Paired Plasma Concentration
This sample was taken as close to the time of genital tract sample as possible
Measured: 8-10 hours after raltegravir dose
Male Time Since Last Dose
This measure describes the amount of time that expired between when the dose was administered and when the sample was taken
Measured: 8-10 hours after raltegravir dose
Female Time Since Last Dose
This measure describes the amount of time that expired between when the dose was administered and when the sample was taken
Measured: 8-10 hours after raltegravir dose
Male Genital Tract:Plasma Concentration Ratio
Units of raltegravir concentration for genital tract and plasma sample are ng/mL
Measured: 8-10 hours after raltegravir dose
Female Genital Tract:Plasma Concentration Ratio
Units of raltegravir concentration for genital tract and plasma sample are ng/mL
Measured: 8-10 hours after raltegravir dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2011
- Study completionJun 2011
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 HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Robert Dicenzo, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745368
- Sponsor's protocol ID
- 33113
- Status last verified
- Sep 2012
- First submitted
- 1 Sep 2008
- Last updated
- 10 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women
- ClinicalTrials.gov ID
- NCT00745368
- Acronym / sponsor ID
- 33113
- Conditions
- HIV Infections
- Keywords
- HIV, Raltegravir, pharmacokinetics, Treatment Experienced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Posted 10 Oct 2012
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 research study is to determine how much raltegravir gets into the male and female genital tract.
Detailed description
Although we have many medications to fight the HIV virus, very little is known about how much of these medications get into the genital tract. Raltegravir is a new HIV medication that blocks HIV growth and lowers the amount of virus in the blood in a way that is different than all other currently available HIV medications. Raltegravir was recently approved by the Food and Drug Administration (FDA) for use in HIV infected patients, but there is very little information concerning how much raltegravir will reach the genital tract of men or women. The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raltegravir | Experimental | Drug: RaltegravirRaltegravir 400 mg tablets twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documentation of blood seropositive for HIV based on self report and confirmed by ELISA and Western blot or detectable HIV RNA
Key exclusion criteria (12 listed)
- Neoplasms
- Women who are pregnant or nursing
- History or current evidence of any significant acute or chronic medical illness that in the opinion of the investigator would preclude the subject from safely participating in the study
- Current use of phenobarbital, phenytoin, or rifampin
- Any major surgery within 4 weeks of enrollment
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 |
|---|---|---|
| Raltegravir400 mg tablets twice daily during duration of trial | Drug | Raltegravir |
Primary outcome
Raltegravir Male Genital Tract Concentration
Time frame: 8-10 hours after raltegravir dose
Raltegravir Female Genital Tract Concentration
Time frame: 8-10 hours after raltegravir dose
Male Paired Plasma Concentration
Time frame: 8-10 hours after raltegravir dose
This sample was taken as close to the time of genital tract sample as possible
Female Paired Plasma Concentration
Time frame: 8-10 hours after raltegravir dose
This sample was taken as close to the time of genital tract sample as possible
Male Time Since Last Dose
Time frame: 8-10 hours after raltegravir dose
This measure describes the amount of time that expired between when the dose was administered and when the sample was taken
Female Time Since Last Dose
Time frame: 8-10 hours after raltegravir dose
This measure describes the amount of time that expired between when the dose was administered and when the sample was taken
Male Genital Tract:Plasma Concentration Ratio
Time frame: 8-10 hours after raltegravir dose
Units of raltegravir concentration for genital tract and plasma sample are ng/mL
Female Genital Tract:Plasma Concentration Ratio
Time frame: 8-10 hours after raltegravir dose
Units of raltegravir concentration for genital tract and plasma sample are ng/mL
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raltegravir in people with HIV Infections, run by University of Rochester 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 4 inclusion and 12 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 10 Oct 2012. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2012). 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?
Raltegravir Male Genital Tract Concentration (time frame: 8-10 hours after raltegravir dose). The study lists 8 primary outcomes in all. 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 10 Oct 2012; AzTrials last refreshed its copy on 7 Nov 2026.