HIV/AIDSPhase 1NCT00775294
Study in Healthy Males to Measure Maraviroc in Blood, Saliva, Seminal Fluid, and Rectal Tissue
A Phase 1 study testing Maraviroc in people with HIV/AIDS, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This study is being conducted to look at how the body handles the drug maraviroc. It will measure the amount of maraviroc in blood, semen, saliva and in the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the oral, reproductive and intestinal tracts. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Maraviroc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Mar 2010
- 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 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between the ages of 18 and 49 years, inclusive, with intact genital tract and gastrointestinal tract. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG for individuals >35yo and clinical laboratory tests).
- Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >/=50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Subjects with a history of having a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract.
- Subjects with inflammatory bowel diseases (ulcerative colitis or Crohn's disease) and have a clearly defined diagnosis of irritable bowel syndrome.
- Subject who is unwilling to refrain from any sexual activity including intercourse and masturbation for 72 hours prior study visit Day 1 and until discharge from the study.
- Subject who is unwilling to refrain from rectal insertion of medical/recreation devices and products and from receptive anal intercourse, for 72 hours before study visit Day -1 and through 7 days after the last biopsy unless instructed otherwise by the investigators.
- History of febrile illness within 5 days prior to the first dose.
Show all 21Show fewer
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- A positive result for HIV.
- Active hepatitis B infection as defined by a positive Hepatitis B surface antigen (HbsAg) OR a positive Hepatitis B core antibody with a negative Hepatitis B surface antibody (HBsAb).
- Active hepatitis C infection as defined by anti-hepatitis C virus serology (as determined by multi-antigen EIA) and detectable HCV RNA.
- A positive test for syphilis, gonorrhea, Chlamydia, HSV-2 (active lesions) or trichomonas at screening.
- History of regular alcohol consumption exceeding 14 drinks (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of spirits) per week.
- Participation in a clinical study within 4 months preceding the first dose of trial medication.
- Participation in a rectal biopsy study in the 12 months preceding the first dose of trial medication.
- Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication. Herbal supplements must be discontinued 14 days prior to the first dose of trial medication. As an exception, acetaminophen may be used at doses of </= 1 g/day
- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Unwilling to abstain from alcohol use from 24 hours prior to the first dose of study medication until after the follow-up visit.
- Unwilling to abstain from cigarette smoking completely during inpatient pharmacokinetic visits and unwilling to limit smoking to a maximum of 5 cigarettes per day from 24 hours prior to the start of the study until study completion.
- Unwilling or unable to comply with the dietary restrictions in regard to study drug administration
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Hospitals CTRC
Chapel Hill, North Carolina, 27514
About this study
Official title: A Phase IV, Open Label Study in Healthy Male Subjects to Investigate the Extent of Maraviroc Exposure in Blood, Saliva, Seminal Fluid, and Rectal Mucosal Tissue Following Single and Multiple Dosing of Maraviroc
This study is being conducted to look at how the body handles the drug maraviroc. It will measure the amount of maraviroc in blood, semen, saliva and in the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the oral, reproductive and intestinal tracts. It is believed that the presence of this drug in these areas may be beneficial in preventing the AIDS virus (HIV) from being passed from one person to another. The study will take samples of blood, saliva, semen and rectal mucosal tissue to measure drug levels. This study will also collect information on side effects.
- Conditions
- HIV/AIDS
- Being tested
- Maraviroc
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaravirocDrug
Also called Selzentry
Healthy male volunteers will take maraviroc 300 mg orally twice daily for 15 doses (8 days)
| Study group | Role | What they receive |
|---|---|---|
| maraviroc | Experimental | Single arm trial looking at the pharmacokinetics of maraviroc in healthy volunteers. Receives: Drug: Maraviroc |
What is being measured
The primary outcome is the main question the study is designed to answer.
To generate individual maraviroc pharmacokinetic parameters in seminal plasma after single and multiple dosing
Measured: Study Days 1, 7, and 8
To generate composite maraviroc pharmacokinetic parameters in rectal tissue after single and multiple dosing
Measured: Study days 1 and 7 or 8
Secondary outcomes (1)
To generate matrix:blood plasma ratios of maraviroc in semen and rectal tissue after single and multiple dosing
Measured: Days 1, 7 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Angela DM Kashuba, PharmD, Principal investigator, UNC Eshelman School of PharmacyKristine B Patterson, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775294
- Sponsor's protocol ID
- IRB 08-0418
- Status last verified
- May 2011
- First submitted
- 17 Oct 2008
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Brown KC, Patterson KB, Malone SA, Shaheen NJ, Prince HM, Dumond JB, Spacek MB, Heidt PE, Cohen MS, Kashuba AD. Single and multiple dose pharmacokinetics of maraviroc in saliva, semen, and rectal tissue of healthy HIV-negative men. J Infect Dis. 2011 May 15;203(10):1484-90. doi: 10.1093/infdis/jir059.
PubMed 21502084
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open Label Study in Healthy Male Subjects to Investigate the Extent of Maraviroc Exposure in Blood, Saliva, Seminal Fluid, and Rectal Mucosal Tissue Following Single and Multiple Dosing of Maraviroc
- ClinicalTrials.gov ID
- NCT00775294
- Acronym / sponsor ID
- IRB 08-0418
- Conditions
- HIV/AIDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 20 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.
This study is being conducted to look at how the body handles the drug maraviroc. It will measure the amount of maraviroc in blood, semen, saliva and in the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the oral, reproductive and intestinal tracts. It is believed that the presence of this drug in these areas may be beneficial in preventing the AIDS virus (HIV) from being passed from one person to another. The study will take samples of blood, saliva, semen and rectal mucosal tissue to measure drug levels. This study will also collect information on side effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| maraviroc | Experimental | Drug: MaravirocSingle arm trial looking at the pharmacokinetics of maraviroc in healthy volunteers. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects between the ages of 18 and 49 years, inclusive, with intact genital tract and gastrointestinal tract. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG for individuals >35yo and clinical laboratory tests).
- Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >/=50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Key exclusion criteria (21 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Subjects with a history of having a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract.
- Subjects with inflammatory bowel diseases (ulcerative colitis or Crohn's disease) and have a clearly defined diagnosis of irritable bowel syndrome.
- Subject who is unwilling to refrain from any sexual activity including intercourse and masturbation for 72 hours prior study visit Day 1 and until discharge from the study.
- Subject who is unwilling to refrain from rectal insertion of medical/recreation devices and products and from receptive anal intercourse, for 72 hours before study visit Day -1 and through 7 days after the last biopsy unless instructed otherwise by the investigators.
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 |
|---|---|---|
| MaravirocAlso: SelzentryHealthy male volunteers will take maraviroc 300 mg orally twice daily for 15 doses (8 days) | Drug | maraviroc |
Primary outcome
To generate individual maraviroc pharmacokinetic parameters in seminal plasma after single and multiple dosing
Time frame: Study Days 1, 7, and 8
To generate composite maraviroc pharmacokinetic parameters in rectal tissue after single and multiple dosing
Time frame: Study days 1 and 7 or 8
1 secondary outcome
To generate matrix:blood plasma ratios of maraviroc in semen and rectal tissue after single and multiple dosing
Time frame: Days 1, 7 and 8
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 13 May 2011.
- Derived from this study: PubMed 21502084Brown KC, Patterson KB, Malone SA, Shaheen NJ, Prince HM, Dumond JB, Spacek MB, Heidt PE, Cohen MS, Kashuba AD. Single and multiple dose pharmacokinetics of maraviroc in saliva, semen, and rectal tissue of healthy HIV-negative men. J Infect Dis. 2011 May 15;203(10):1484-90. doi: 10.1093/infdis/jir059.
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Angela DM Kashuba, PharmD principal investigator
UNC Eshelman School of Pharmacy
Kristine B Patterson, MD principal investigator
University of North Carolina, Chapel Hill
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 Maraviroc in people with HIV/AIDS, run by University of North Carolina, Chapel Hill 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 21 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 May 2011. 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?
To generate individual maraviroc pharmacokinetic parameters in seminal plasma after single and multiple dosing (time frame: Study Days 1, 7, and 8). The study lists 2 primary outcomes in all. 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 NCT00775294, which also lists 1 linked publication.
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 May 2011.