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Infection, Human Immunodeficiency VirusPhase 1NCT01231542

Phase 1, Open Label, Two Arm, Fixed Sequence Study to Evaluate the Effect of Rifampin and Rifabutin on GSK1349572 Pharmacokinetics in Healthy Male and Female Volunteers

A Phase 1 study testing GSK1349572, Rifampin and Rifabutin in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United States.

Completed

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

Official record
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Trial summary

This study will be a phase I, open label, two arm, fixed sequence crossover study to investigate the effect of rifampin and rifabutin on the steady state pharmacokinetics (PK) of GSK1349572 and the safety and tolerability of GSK1349572 and rifamycin co-administration. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Infection, Human Immunodeficiency Virus
What is being tested?
GSK1349572, Rifampin and Rifabutin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
May 2011to Dec 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and electrocardiogram (ECG).
  • Within 28 or fewer days prior to enrollment, a complete blood count with differential, comprehensive serum chemistry profile, human immunodeficiency virus (HIV) antibody test, and Hepatitis C antibody test will be performed, with the following laboratory values:
  • Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin less than or equal to upper limit of normal (ULN)
  • Hemoglobin greater than or equal to 12.0 for men, greater than or equal to11.0 for women
  • Serum creatinine less than or equal to1.5 mg/dL
  • Platelet count greater than or equal to 125,000 /cu mm
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  • Absolute neutrophil count greater than or equal to 1250 /cu mm
  • HIV antibody test negative
  • Hepatitis C antibody negative
  • Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
  • A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<147 pmol/L) is confirmatory]. or Child-bearing potential and agrees to use one of the contraception methods listed in the protocol for the time period between screening and dosing of study drugs to sufficiently minimize the risk of pregnancy at that point. Female subjects must also agree to use contraception throughout the study and until two weeks after the last dose of study medications.
  • Body weight in the range 53-100 kg (inclusive).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Who cannot join

  • The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days or 5 half-lives (whichever is longer).
  • History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) 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, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  • If heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
  • History of regular alcohol consumption within 6 months of the study defined as:
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  • An average weekly intake of >14 drinks/week for men or >7 drinks/week for women.
  • Any illicit drug use within the preceding 2 months.
  • Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
  • Pregnant females as determined by positive serum or urine human chorionic gonadotrophin (hCG) test at screening or prior to dosing.
  • Lactating females.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Subjects with a history of cholecystectomy, peptic ulceration, inflammatory bowel disease or pancreatitis should be excluded.
  • History/evidence of clinically significant pulmonary disease.
  • History of significant renal or hepatobiliary diseases.
  • History of severe or serious psychiatric disease ever requiring hospitalization, history of suicidal ideation or suicidal attempt, or undergoing psychiatric treatment.
  • Site investigator suspicion of active tuberculosis (TB).
  • History of Gilbert's disease.
  • Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination) per protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Baltimore, Maryland, 21287-5554

Other trials in United States

About this study

This study will be a phase I, open label, two arm, fixed sequence crossover study to investigate the effect of rifampin and rifabutin on the steady state pharmacokinetics (PK) of GSK1349572 and the safety and tolerability of GSK1349572 and rifamycin co-administration. Subjects enrolled in Arm 1 will receive GSK1349572 50 mg once daily for 7 days, GSK1348572 50 mg twice daily for 7 days, and GSK1349572 50 mg twice daily in combination with rifampin 600 mg once daily for 14 days. Subjects in Arm 2 will receive GSK1349572 50 mg once daily for 7 days and GSK1349572 50 mg once daily in combination with rifabutin 300 mg once daily for 14 days. Serial PK sampling will be completed following the last dose of each treatment. Safety and tolerability will be assessed throughout the study through assessment of adverse events (AEs), and clinical laboratory tests.

This study will be conducted at one center in the US with healthy adult male and female subjects.

Being tested
GSK1349572, Rifampin, Rifabutin
Keywords
GSK1349572, pharmacokinetics, dolutegravir, integrase, rifabutin, rifampin
Medical subject headings
Infections, Acquired Immunodeficiency Syndrome

What participants receive

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

  • GSK1349572Drug

    GSK1349572 is an experimental drug for the treatment of HIV. GSK1349572 is in the integrase inhibitor class. It is not yet approved by the FDA.

  • RifampinDrug

    Also called RIFADIN. RIFADIN is a trademark of Sanofi-Aventis

    Rifampin is approved by the FDA for the treatment of tuberculosis.

  • RifabutinDrug

    Also called MYCOBUTIN. MYCOBUTIN is a trademark of Pfizer

    Rifabutin is approved by the FDA for the treatment of tuberculosis.

Study groups in NCT01231542
Study groupRoleWhat they receive
Arm 1ExperimentalSubjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. Subjects enrolled in Arm 1 will receive GSK1349572 50 mg once daily for 7 days, GSK1348572 50 mg twice daily for 7 days, and GSK1349572 50 mg twice daily in combination with rifampin 600 mg once daily for 14 days.
Receives: Drug: GSK1349572; Drug: Rifampin
Arm 2ExperimentalSubjects will have a screening visit within 30 days prior to the first dose of study drug, two treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. Subjects in Arm 2 will receive GSK1349572 50 mg once daily for 7 days and GSK1349572 50 mg once daily in combination with rifabutin 300 mg once daily for 14 days.
Receives: Drug: GSK1349572; Drug: Rifabutin

What is being measured

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

  1. Steady state plasma GSK1349572 concentration at the end of the dosing interval (Cτ)

    Measured: 28 days

  2. maximum concentration (Cmax)

    Measured: 28 days

  3. area under the time-concentration curve over the dosing interval (AUC(0-τ))

    Measured: 28 days

  4. AUC for a 24-hour interval (AUC(0-24)

    Measured: 28 days

Secondary outcomes (7)

  1. Subjects with grade 2 or higher adverse events

    Measured: 28 days

  2. Steady state plasma GSK1349572 minimum plasma concentration (Cmin)

    Measured: 28 days

  3. time of minimum concentration (tmin)

    Measured: 28 days

  4. pre-dose concentration (C0)

    Measured: 28 days

  5. time of maximum concentration (tmax)

    Measured: 28 days

  6. apparent terminal half-life (t1/2)

    Measured: 28 days

  7. apparent oral clearance (CL/F)

    Measured: 28 days

Timeline

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

  1. First posted1 Nov 2010 (estimated)
  2. Study startMay 2011
  3. Primary completionNov 2011
  4. Study completionDec 2011

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01231542
Sponsor's protocol ID
113099
Status last verified
Jun 2017
First submitted
28 Oct 2010
Last updated
8 Jun 2017
Results posted
No
Data monitoring committee
No

Publications

  • Kawuma AN, Wasmann RE, Dooley KE, Boffito M, Maartens G, Denti P. Population Pharmacokinetic Model and Alternative Dosing Regimens for Dolutegravir Coadministered with Rifampicin. Antimicrob Agents Chemother. 2022 Jun 21;66(6):e0021522. doi: 10.1128/aac.00215-22. Epub 2022 May 23.

    PubMed 35604212

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK1349572, Rifampin and Rifabutin in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare 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 13 inclusion and 19 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 8 Jun 2017. 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?

Steady state plasma GSK1349572 concentration at the end of the dosing interval (Cτ) (time frame: 28 days). The study lists 4 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 NCT01231542, 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 8 Jun 2017.

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