HIVNCT01045265

Concentrations of Raltegravir in the Semen of HIV-Infected Men

An observational study of HIV, run by Canadian Immunodeficiency Research Collaborative at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this study is to determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dose interval. The secondary objective is to determine the extend of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing… Read more about this study

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: HIV
What is being tested?: Seminal plasma pharmacokinetics
How many people: 16 participants
Where: 2 sitesCanada
Study dates: Dec 2009to Jul 2012
Phase: Observational
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
Men only
Healthy volunteers accepted
Adult, Older adult

Study population: 12 HIV-positive males

Who may be able to join

HIV infected male
18 years old or older
on raltegravir twice daily as part of their antiretroviral regimen for at least 3 months prior to screening
viral load < 50 copies/mL at least one month prior to enrolling
able to read, understand and sign a written informed consent prior to initiation of the study
medically stable at the time of the study, with no evidence of acute illness

Who cannot join

having difficulty adhering to current antiretroviral therapy
patient is expected to have difficulties adhering with study protocol
patients with malignancy, or acute renal or liver disease
patient with active AIDS-defining illness
patient with any medical, psychiatric or other circumstance that may impede the provision of informed consent
patient with any of the following abnormalities at the time of screening:

Show all 12Show fewer

hemoglobin < 85 g/L
absolute neutrophil count < 1000 cells/uL
platelet count < 50,000 cells/ microleter (uL)
aspartate aminotransferase (AST), alanine transaminase (ALT) or total bilirubin > 3 times the upper limit of normal
serum creatinine > 1.5 times upper limit of normal
patient receiving concomitant therapy with rifampin or St. John's wort

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

The Ottawa Hospital
Ottawa, Ontario
Canadian Immunodeficiency Research Collaborative
Toronto, Ontario, M5B 1L6

Other trials in Canada

About this study

Official title: Study to Determine the Concentrations of Raltegravir in Semen, the Seminal to Plasma Ratio of Raltegravir and the Variability in Seminal to Plasma Ratios Over the Raltegravir Dosing Period.

The objective of this study is to determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dose interval.

The secondary objective is to determine the extend of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval, to determine the area under the concentration time curve of raltegravir in semen, and to determine the variability in the penetration of raltegravir into the seminal compartment over the dosing period.

Read the detailed description

The patient population will consist of 12 male HIV-positive patients who have been receiving stable antiretroviral therapy that includes raltegravir for a minimum of three months. Patients will be enrolled from one clinic in downtown Toronto and a hospital affiliated HIV specialty clinic in Ottawa, Ontario. Eligible patients will have evidence of full virologic suppression (HIV viral load < 50 copies/mL) at least one month prior to enrollment in the study. No changes will be made to the patients antiretroviral therapy during the course of the study.

Conditions: HIV
Being tested: Seminal plasma pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Seminal plasma pharmacokineticsOther
Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.

Study groups in NCT01045265
Study group	Role	What they receive
Raltegravir treated men		Single group study of seminal plasma pharmacokinetics of raltegravir in men receiving chronic raltegravir therapy Receives: Other: Seminal plasma pharmacokinetics

What is being measured

The primary outcome is the main question the study is designed to answer.

Seminal Concentrations of Raltegravir.
Determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dosing interval.
Measured: 6 months

Secondary outcomes (3)

Semen to Plasma Raltegravir Concentrations
Determine the extent of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval.
Measured: 6 months
Seminal Distribution of Raltegravir
Determine the area under the concentration time curve of raltegravir in semen.
Measured: 6 months
Semen to Plasma Distribution of Raltegravir
Determine the variability in the penetration of raltegravir into the seminal compartment over the raltegravir dosing period.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Jul 2012

First posted11 Jan 2010 (estimated)
Study startDec 2009
Primary completionSep 2011
Study completionJul 2012

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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01045265
Sponsor's protocol ID: MISP35369
Status last verified: Aug 2014
First submitted: 8 Jan 2010
Last updated: 13 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Determine the Concentrations of Raltegravir in Semen, the Seminal to Plasma Ratio of Raltegravir and the Variability in Seminal to Plasma Ratios Over the Raltegravir Dosing Period.
ClinicalTrials.gov ID: NCT01045265
Acronym / sponsor ID: MISP35369
Conditions: HIV
Study type: Observational
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Canadian Immunodeficiency Research CollaborativeUniversity, hospital or other
Study start: Dec 2009
Primary completion: Sep 2011 (actual)
Study completion: Jul 2012 (actual)
First posted: 11 Jan 2010 (estimated)
Results: Posted 13 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dose interval.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Raltegravir treated men	–	Other: Seminal plasma pharmacokineticsSingle group study of seminal plasma pharmacokinetics of raltegravir in men receiving chronic raltegravir therapy

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: 12 HIV-positive males

Key inclusion criteria (6 listed)

HIV infected male
18 years old or older
on raltegravir twice daily as part of their antiretroviral regimen for at least 3 months prior to screening
viral load < 50 copies/mL at least one month prior to enrolling
able to read, understand and sign a written informed consent prior to initiation of the study

Key exclusion criteria (12 listed)

having difficulty adhering to current antiretroviral therapy
patient is expected to have difficulties adhering with study protocol
patients with malignancy, or acute renal or liver disease
patient with active AIDS-defining illness
patient with any medical, psychiatric or other circumstance that may impede the provision of informed consent

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
Seminal plasma pharmacokineticsMeasure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.	Other	Raltegravir treated men

Primary outcome

Seminal Concentrations of Raltegravir.
Time frame: 6 months
Determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dosing interval.

3 secondary outcomes

Semen to Plasma Raltegravir Concentrations
Time frame: 6 months
Seminal Distribution of Raltegravir
Time frame: 6 months
Semen to Plasma Distribution of Raltegravir
Time frame: 6 months

Results and safety

Results posted to the registry on 13 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Men on Raltegravir	16	16

Primary outcome: Seminal Concentrations of Raltegravir.

Time frame: 6 months. Median (Inter-Quartile Range). Unit: mg/l

Measure	16 Male HIV-positive Patients n = 16
C-min	0.18 (0.13 to 0.24)
C-max	1.91 (1.46 to 4.33)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: collected over 1.5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Men on Raltegravir	0 of 16 (0%)	0 of 16 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
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.

Mona Loutfy, MD, MPH principal investigator

Maple Leaf Medical Research

Tony Antoniou principal investigator

Unity Health Toronto

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV, run by Canadian Immunodeficiency Research Collaborative at 2 sites in Canada.

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 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 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. 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 13 Aug 2014). 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?

Seminal Concentrations of Raltegravir. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01045265.

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 13 Aug 2014.