HealthyPhase 1NCT01459315
GSK1349572 Exposure in Blood, Seminal Fluid, and Rectal Fluid and Tissue in Healthy Male Subjects
A Phase 1 study testing dolutegravir in people with Healthy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to describe drug concentrations in blood plasma, rectal fluid, rectal tissue, and seminal fluid in HIV negative men following single and multiple doses of an investigational HIV medication known as GSK1349572 (dolutegravir). 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
- Healthy
- What is being tested?
- dolutegravir
- 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
- Nov 2011to Dec 2012
- 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.
- Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight greater than 50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document
- Willing and able to comply with all 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
- Subjects with a history of gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract.
- Subjects with a history of vasectomy, prostatectomy, or any other procedure altering the male reproductive tract.
- Subjects with inflammatory bowel diseases (ulcerative colitis or Crohn's disease), irritable bowel syndrome, or other abnormalities of the colorectal mucosa, or significant colorectal symptom(s)
- Subject who is unwilling to refrain from any sexual activity for 72 hours before study visit Day 0 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 0 and through 7 days after the last biopsy.
Show all 25Show fewer
- History of febrile illness within 14 days prior to the first dose.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- A positive result for HIV, Hepatitis B surface antigen or Hepatitis B core antibody screening tests or anti-hepatitis C virus serology
- A positive test for syphilis, rectal gonorrhea, chlamydia, or HSV-2 (active lesions) at screening.
- Current 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 or unwilling to abstain from alcohol use from 48 hours prior to the first dose of study medication until after the follow-up visit.
- History of regular use of tobacco- or nicotine-containing products exceeding an equivalent of 5 cigarettes per day within three months prior to screening or unwilling to abstain from cigarette smoking completely during visits.
- Treatment with an investigational drug within 4 months preceding the first dose of trial medication.
- Participated in a rectal biopsy study in the 12 months preceding the first dose of trial medication.
- Use of clinically significant prescription or non-prescription drugs within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication
- Blood donation of approximately 1 pint (≥473 mL) within 56 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- History of confirmed allergy to prescription or non-prescription products.
- Unable or unwilling to swallow oral medications.
- History of bleeding or clotting disorders including disseminated intravascular coagulation, hemophilia Henoch-Schönlein purpura (allergic purpura), hereditary hemorrhagic telangiectasia, thrombocytopenia, thrombophilia or Von Willebrand's disease.
- The subject's blood pressure is outside the range of 90-140/45-90 mmHg, or heart rate is outside the range of 45-100 bpm.
- Clinically significant abnormalities to pulse or conduction observed on ECG
- Unwilling or unable to comply with dietary restrictions
- Any other reason or condition that would make participation in the study unsafe, complicate interpretation of study outcome data, or interfere with achieving the study objectives.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Phase I, Open-Label Study in Healthy Male Subjects Describing GSK1349572 Exposure in Blood Plasma, Seminal Fluid and Rectal Mucosal Tissue Following Single and Multiple Dosing
The purpose of this study is to describe drug concentrations in blood plasma, rectal fluid, rectal tissue, and seminal fluid in HIV negative men following single and multiple doses of an investigational HIV medication known as GSK1349572 (dolutegravir).
Read the detailed description
The purpose of this study is to determine first dose and steady-state concentrations of GSK1349572 in seminal fluid, rectal mucosal fluid, and rectal tissue compared to blood plasma (BP) in HIV-1 negative males. GSK1349572 is an investigational next generation integrase inhibitor currently in Phase III trials. Understanding the concentrations of GSK1349572 in multiple male biological compartments will inform its role in preventing HIV infection by making an HIV-infected person less likely to transmit the virus, and protecting uninfected persons from acquiring the virus.
- Conditions
- Healthy
- Being tested
- dolutegravir
- Keywords
- Healthy, Male, GSK1349572, Dolutegravir, DTG, Integrase, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dolutegravirDrug
Also called GSK1349572, DTG
Subjects will take a GSK1349572 (dolutegravir) 50mg tablet by mouth once daily for 8 days. GSK1349572 concentrations will be measured in blood plasma, seminal fluid, rectal fluid, and rectal tissue over 24 hours after a single dose and over two 24 hour periods once steady state is reached. Blood plasma will be collected pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 18, and 24 hours after dosing. Each subject will also provide a total of 9 seminal and rectal fluid samples and have 2 rectal tissue biopsies performed pre-dose or at 1, 3, 6, 12, 18, or 24 hours after receiving single or multiple doses.
| Study group | Role | What they receive |
|---|---|---|
| GSK1349572 | Experimental | Not described Receives: Drug: dolutegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration versus time curve (AUC) in blood plasma after a single dose
The area under the concentration time curve will be determined from all sample collection time points over a 24 hour period. Sample collection for blood plasma will occur pre-dose, then 1, 2, 3, 4, 5, 6, 8, 12, 18, and 24 hours post-dose. AUCs will be determined for individual subjects and for all subjects combined following a single dose.
Measured: 24 hours
Peak concentration (Cmax) in blood plasma after a single dose
Peak drug concentration in blood plasma after the first dose will be determined from samples taken pre-dose, then at 1, 2, 3, 4, 5, 6, 8, 12, 18, and 24 hours post-dose in each subject and across all subjects.
Measured: 24 hours
Area under the concentration versus time curve (AUC) in blood plasma at steady state
The area under the concentration time curve will be determined from all sample collection time points over a 24 hour period. Sample collection for blood plasma will occur pre-dose, then 1, 2, 3, 4, 5, 6, 8, 12, 18, and 24 hours post-dose. AUCs will be determined for individual subjects and for all subjects combined at steady state.
Measured: 24 hours
Peak concentration (Cmax) in blood plasma at steady state
Peak drug concentration in blood plasma at steady state will be determined from samples taken pre-dose, then at 1, 2, 3, 4, 5, 6, 8, 12, 18, and 24 hours post-dose in each subject and across all subjects.
Measured: 24 hours
Area under the concentration versus time curve (AUC) in seminal fluid after a single dose
The area under the concentration time curve after a single dose will be determined from all sample collection time points over a 24 hour period for seminal fluid. Sample collection will occur pre-dose and at two time points per subject 1, 3, 6, 12, 18, or 24 hours post-dose. AUCs will be determined for all subjects combined.
Measured: 24 hours
Peak drug concentration (Cmax) in seminal fluid after a single dose
Peak drug concentration in seminal fluid will be determined from samples taken pre-dose, then at 2 time points per subject 1, 3, 6, 12, 18, or 24 hours post-dose. Cmax will be determined for all subjects combined.
Measured: 24 hours
Area under the concentration versus time curve (AUC) for seminal fluid at steady state
The area under the concentration time curve at steady state for seminal fluid will be determined from all sample collection time points over a 48 hour period for seminal fluid. Sample collection will occur at 1, 3, 6, 12, 18, or 24 hours post-dose over 48 hours with 3 collections per subject in each 24 hour period. AUCs will be determined for each subject and across all subjects.
Measured: 48 hours
Peak drug concentration (Cmax) for seminal fluid at steady state
Peak drug concentration (Cmax) at steady state for seminal fluid will be determined from all sample collection time points over a 48 hour period. Sample collection will occur at 1, 3, 6, 12, 18, or 24 hours post-dose over 48 hours with 3 collections per subject in each 24 hour period. Cmax will be determined for each subject and across all subjects.
Measured: 24 hours
Area under the concentration versus time curve (AUC) for rectal fluid after a single dose
The area under the concentration time curve after a single dose will be determined from all sample collection time points over a 24 hour period for rectal fluid. Sample collection will occur pre-dose and at two time points per subject 1, 3, 6, 12, 18, or 24 hours post-dose. AUCs will be determined for all subjects combined.
Measured: 24 hours
Peak drug concentration (Cmax) in rectal fluid after a single dose
Peak drug concentration in rectal fluid will be determined from samples taken pre-dose, then at 2 time points per subject 1, 3, 6, 12, 18, or 24 hours post-dose. Cmax will be determined for all subjects combined.
Measured: 24 hours
Area under the concentration versus time curve (AUC) for rectal fluid at steady state
The area under the concentration time curve at steady state for rectal fluid will be determined from all sample collection time points over a 48 hour period. Sample collection will occur at 1, 3, 6, 12, 18, or 24 hours post-dose over 48 hours with 3 collections per subject in each 24 hour period. AUCs will be determined for each subject and across all subjects.
Measured: 48 hours
Peak drug concentration (Cmax) for rectal fluid at steady state
Peak drug concentration (Cmax) at steady state for rectal fluid will be determined from all sample collection time points over a 48 hour period. Sample collection will occur at 1, 3, 6, 12, 18, or 24 hours post-dose over 48 hours with 3 collections per subject in each 24 hour period. Cmax will be determined for each subject and across all subjects.
Measured: 48 hours
Area under the concentration versus time curve (AUC) for rectal tissue after a single dose
The area under the concentration time curve for rectal tissue after a single dose will be determined from all sample collection time points over a 24 hour period. One sample collection will be performed per subject at either 1, 3, 6, 12, 18, or 24 hours post-dose and AUC will be determined for all subjects combined.
Measured: 24 hours
Peak drug concentration (Cmax) for rectal tissue after a single dose
Peak drug concentration in rectal tissue after a single dose will be determined from all sample collection time points over a 24 hour period. One sample collection will be performed per subject at either 1, 3, 6, 12, 18, or 24 hours post-dose and Cmax will be determined for all subjects combined.
Measured: 24 hours
Area under the concentration versus time curve (AUC) for rectal tissue at steady state
The area under the concentration time curve for rectal tissue at steady state will be determined from all sample collection time points over a 24 hour period. One sample collection will be performed per subject at either 1, 3, 6, 12, 18, or 24 hours post-dose and AUC will be determined for all subjects combined.
Measured: 24 hours
Peak drug concentration (Cmax) for rectal tissue at steady state
Peak drug concentration in rectal tissue at steady state will be determined from all sample collection time points over a 24 hour period. One sample collection will be performed per subject at either 1, 3, 6, 12, 18, or 24 hours post-dose and Cmax will be determined for all subjects combined.
Measured: 24 hours
Area under the concentration versus time curve ratios after a single dose
AUC ratios will be determined to compare blood plasma concentrations after a single dose with concentrations in rectal tissue, rectal fluid, and seminal fluid.
Measured: 24 hours
Area under the concentration time curve ratios at steady state
AUC ratios will be determined to compare blood plasma concentrations at steady state with concentrations in rectal tissue, rectal fluid, and seminal fluid.
Measured: 24 hours
Accumulation ratio
Area under the concentration time curve (AUC) in each matrix at steady state will be compared to AUC after a single dose to determine accumulation ratios.
Measured: 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Not applicable
- 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
- GlaxoSmithKline
- Responsible party
- Principal investigator, Kristine Patterson, MD, University of North Carolina, Chapel Hill
- Investigators
- Kristine B Patterson, MD, Principal investigator, University of North Carolina, Chapel HillBenjamin N Greener, PharmD, Study director, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459315
- Sponsor's protocol ID
- 11-1733
- Status last verified
- Jul 2013
- First submitted
- 21 Oct 2011
- Last updated
- 4 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-Label Study in Healthy Male Subjects Describing GSK1349572 Exposure in Blood Plasma, Seminal Fluid and Rectal Mucosal Tissue Following Single and Multiple Dosing
- ClinicalTrials.gov ID
- NCT01459315
- Acronym / sponsor ID
- 11-1733
- Conditions
- Healthy
- Keywords
- Healthy, Male, GSK1349572, Dolutegravir, DTG, Integrase, HIV
- 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
- GlaxoSmithKline
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Oct 2011 (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 describe drug concentrations in blood plasma, rectal fluid, rectal tissue, and seminal fluid in HIV negative men following single and multiple doses of an investigational HIV medication known as GSK1349572 (dolutegravir).
Detailed description
The purpose of this study is to determine first dose and steady-state concentrations of GSK1349572 in seminal fluid, rectal mucosal fluid, and rectal tissue compared to blood plasma (BP) in HIV-1 negative males. GSK1349572 is an investigational next generation integrase inhibitor currently in Phase III trials. Understanding the concentrations of GSK1349572 in multiple male biological compartments will inform its role in preventing HIV infection by making an HIV-infected person less likely to transmit the virus, and protecting uninfected persons from acquiring the virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK1349572 | Experimental | Drug: dolutegravir |
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.
- Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight greater than 50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Key exclusion criteria (25 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- Subjects with a history of gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract.
- Subjects with a history of vasectomy, prostatectomy, or any other procedure altering the male reproductive tract.
- Subjects with inflammatory bowel diseases (ulcerative colitis or Crohn's disease), irritable bowel syndrome, or other abnormalities of the colorectal mucosa, or significant colorectal symptom(s)
- Subject who is unwilling to refrain from any sexual activity for 72 hours before study visit Day 0 and until discharge from the study.
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 |
|---|---|---|
| dolutegravirAlso: GSK1349572, DTGSubjects will take a GSK1349572 (dolutegravir) 50mg tablet by mouth once daily for 8 days. GSK1349572 concentrations will be measured in blood plasma, seminal fluid, rectal fluid, and rectal tissue over 24 hours after a single dose and over two 24 hour periods once steady state is reached. Blood plasma will be collected pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 18, and 24 hours after dosing. Each subject will also provide a total of 9 seminal and rectal fluid samples and have 2 rectal tissue biopsies performed pre-dose or at 1, 3, 6, 12, 18, or 24 hours after receiving single or multiple doses. | Drug | GSK1349572 |
Primary outcome
Area under the concentration versus time curve (AUC) in blood plasma after a single dose
Time frame: 24 hours
The area under the concentration time curve will be determined from all sample collection time points over a 24 hour period. Sample collection for blood plasma will occur pre-dose, then 1, 2, 3, 4, 5, 6, 8, 12, 18, and 24 hours post-dose. AUCs will be determined for individual subjects and for all subjects combined following a single dose.
Peak concentration (Cmax) in blood plasma after a single dose
Time frame: 24 hours
Peak drug concentration in blood plasma after the first dose will be determined from samples taken pre-dose, then at 1, 2, 3, 4, 5, 6, 8, 12, 18, and 24 hours post-dose in each subject and across all subjects.
Area under the concentration versus time curve (AUC) in blood plasma at steady state
Time frame: 24 hours
The area under the concentration time curve will be determined from all sample collection time points over a 24 hour period. Sample collection for blood plasma will occur pre-dose, then 1, 2, 3, 4, 5, 6, 8, 12, 18, and 24 hours post-dose. AUCs will be determined for individual subjects and for all subjects combined at steady state.
Peak concentration (Cmax) in blood plasma at steady state
Time frame: 24 hours
Peak drug concentration in blood plasma at steady state will be determined from samples taken pre-dose, then at 1, 2, 3, 4, 5, 6, 8, 12, 18, and 24 hours post-dose in each subject and across all subjects.
Area under the concentration versus time curve (AUC) in seminal fluid after a single dose
Time frame: 24 hours
The area under the concentration time curve after a single dose will be determined from all sample collection time points over a 24 hour period for seminal fluid. Sample collection will occur pre-dose and at two time points per subject 1, 3, 6, 12, 18, or 24 hours post-dose. AUCs will be determined for all subjects combined.
Peak drug concentration (Cmax) in seminal fluid after a single dose
Time frame: 24 hours
Peak drug concentration in seminal fluid will be determined from samples taken pre-dose, then at 2 time points per subject 1, 3, 6, 12, 18, or 24 hours post-dose. Cmax will be determined for all subjects combined.
Area under the concentration versus time curve (AUC) for seminal fluid at steady state
Time frame: 48 hours
The area under the concentration time curve at steady state for seminal fluid will be determined from all sample collection time points over a 48 hour period for seminal fluid. Sample collection will occur at 1, 3, 6, 12, 18, or 24 hours post-dose over 48 hours with 3 collections per subject in each 24 hour period. AUCs will be determined for each subject and across all subjects.
Peak drug concentration (Cmax) for seminal fluid at steady state
Time frame: 24 hours
Peak drug concentration (Cmax) at steady state for seminal fluid will be determined from all sample collection time points over a 48 hour period. Sample collection will occur at 1, 3, 6, 12, 18, or 24 hours post-dose over 48 hours with 3 collections per subject in each 24 hour period. Cmax will be determined for each subject and across all subjects.
Area under the concentration versus time curve (AUC) for rectal fluid after a single dose
Time frame: 24 hours
The area under the concentration time curve after a single dose will be determined from all sample collection time points over a 24 hour period for rectal fluid. Sample collection will occur pre-dose and at two time points per subject 1, 3, 6, 12, 18, or 24 hours post-dose. AUCs will be determined for all subjects combined.
Peak drug concentration (Cmax) in rectal fluid after a single dose
Time frame: 24 hours
Peak drug concentration in rectal fluid will be determined from samples taken pre-dose, then at 2 time points per subject 1, 3, 6, 12, 18, or 24 hours post-dose. Cmax will be determined for all subjects combined.
Area under the concentration versus time curve (AUC) for rectal fluid at steady state
Time frame: 48 hours
The area under the concentration time curve at steady state for rectal fluid will be determined from all sample collection time points over a 48 hour period. Sample collection will occur at 1, 3, 6, 12, 18, or 24 hours post-dose over 48 hours with 3 collections per subject in each 24 hour period. AUCs will be determined for each subject and across all subjects.
Peak drug concentration (Cmax) for rectal fluid at steady state
Time frame: 48 hours
Peak drug concentration (Cmax) at steady state for rectal fluid will be determined from all sample collection time points over a 48 hour period. Sample collection will occur at 1, 3, 6, 12, 18, or 24 hours post-dose over 48 hours with 3 collections per subject in each 24 hour period. Cmax will be determined for each subject and across all subjects.
Area under the concentration versus time curve (AUC) for rectal tissue after a single dose
Time frame: 24 hours
The area under the concentration time curve for rectal tissue after a single dose will be determined from all sample collection time points over a 24 hour period. One sample collection will be performed per subject at either 1, 3, 6, 12, 18, or 24 hours post-dose and AUC will be determined for all subjects combined.
Peak drug concentration (Cmax) for rectal tissue after a single dose
Time frame: 24 hours
Peak drug concentration in rectal tissue after a single dose will be determined from all sample collection time points over a 24 hour period. One sample collection will be performed per subject at either 1, 3, 6, 12, 18, or 24 hours post-dose and Cmax will be determined for all subjects combined.
Area under the concentration versus time curve (AUC) for rectal tissue at steady state
Time frame: 24 hours
The area under the concentration time curve for rectal tissue at steady state will be determined from all sample collection time points over a 24 hour period. One sample collection will be performed per subject at either 1, 3, 6, 12, 18, or 24 hours post-dose and AUC will be determined for all subjects combined.
Peak drug concentration (Cmax) for rectal tissue at steady state
Time frame: 24 hours
Peak drug concentration in rectal tissue at steady state will be determined from all sample collection time points over a 24 hour period. One sample collection will be performed per subject at either 1, 3, 6, 12, 18, or 24 hours post-dose and Cmax will be determined for all subjects combined.
Area under the concentration versus time curve ratios after a single dose
Time frame: 24 hours
AUC ratios will be determined to compare blood plasma concentrations after a single dose with concentrations in rectal tissue, rectal fluid, and seminal fluid.
Area under the concentration time curve ratios at steady state
Time frame: 24 hours
AUC ratios will be determined to compare blood plasma concentrations at steady state with concentrations in rectal tissue, rectal fluid, and seminal fluid.
Accumulation ratio
Time frame: 24
Area under the concentration time curve (AUC) in each matrix at steady state will be compared to AUC after a single dose to determine accumulation ratios.
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 4 Jul 2013.
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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.
Kristine B Patterson, MD principal investigator
University of North Carolina, Chapel Hill
Benjamin N Greener, PharmD study director
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 dolutegravir in people with Healthy, 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 25 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 4 Jul 2013. 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?
Area under the concentration versus time curve (AUC) in blood plasma after a single dose (time frame: 24 hours). The study lists 19 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 4 Jul 2013.