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HIV InfectionPhase 1NCT00659191

A Healthy Volunteer And Patient Study To Assess The Safety, Tolerability And Pharmacokinetics Of GSK1265744

A Phase 1 study testing GSK1265744 in people with HIV Infection, run by GlaxoSmithKline at 5 sites 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 is a Phase I single and repeat dose escalation study of GSK1265744 in healthy subjects and a single repeat dose cohort in HIV-1 infected subjects. The study is planned to consist of three parts. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infection
What is being tested?
GSK1265744
How many people
58 participants
Where
5 sitesUnited States
Study dates
Feb 2008to Nov 2008
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Parts A and B: The subject is healthy. Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Male or female between 18 and 55 years of age.
  • A female subject is eligible to participate if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who:
  • Is pre-menopausal with a documented bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries) or hysterectomy, or Is post-menopausal defined as 12 months of spontaneous amenorrhea. A follicle stimulating hormone (FSH) level will be performed to confirm a post-menopausal status. For this study, FSH levels > 40 mlU/ml is confirmatory.
  • A male is eligible to enter and participate in the study if he is surgically sterile OR if he either agrees to abstain from sexual intercourse with a female partner or agrees to use a condom/spermicide, in addition to having his female partner use another form of contraception as in protocol
  • Body weight >/ 50 kg (110 lbs.) for men and >/ 45 kg (99 lbs) for women and body mass index (BMI) within the range 18.5-31.0 kg/m2 (inclusive).
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  • A signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening.
  • Subject must be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Part C: HIV-infected cohort only: CD4 cell count >/ 200 cells/mm3 and plasma HIV-1 RNA >/ 5,000 copies/mL.
  • Part C: HIV-infected cohort only: A pre-baseline viral load measurement will be obtained 7-14 days after the screening visit. The pre-baseline viral load must be within 0.7 log of the screening HIV-1 RNA and must meet the screening HIV-1 RNA (i.e., > 5000) requirements for the subject to be included.

Who cannot join

  • As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study.
  • Has a positive pre-study Hepatitis B surface antigen; positive hepatitis C (HCV) antibody or detectable HCV ribonucleic acid (RNA); or positive HIV-1 antibody result. NOTE that a positive HIV-1 antibody result is acceptable for those entering the study as a subject infected with HIV-1 (Part C)
  • Has a history of regular alcohol consumption averaging >7 drinks/week for women or >14 drinks/week for men within 6 months of the screening visit.
  • Note: 1 drink is equivalent to 12 g alcohol = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
  • Unwilling to abstain from alcohol for 48 hours prior to the start of dosing until collection of the final pharmacokinetic sample during each treatment period.
  • Unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
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  • The subject has received an investigational drug or participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
  • Participation in the study would result in donation of blood in excess of 500 mL within a 56 day period.
  • Note: This does not include plasma donation.
  • History or presence of allergy or intolerance to the study drug or its components or drugs of its class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
  • Note: "Study" or "investigational" drugs include GSK1265744 or placebo.
  • 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 should be excluded.
  • Exclusion criteria for screening ECG as outlined in protocol.
  • Evidence of previous myocardial infarction (Does not include ST segment changes associated with repolarization).
  • Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [2nd degree or higher], WPW syndrome).
  • Sinus Pauses > 3 seconds.
  • Any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety for the individual subject.
  • Non-sustained or sustained ventricular tachycardia (>/3 consecutive ventricular ectopic beats).
  • The subject's systolic blood pressure is outside the range of 90-140mmHg, or diastolic blood pressure is outside the range of 45-90mmHg or heart rate is outside the range of 50-100bpm for female subjects or 45-100 bpm for male subjects.
  • History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.
  • History/evidence of clinically significant pulmonary disease.
  • Has a history of regular use of tobacco- or nicotine-containing products within 3 months of the screening visit.
  • The subject has a positive pre-study drug and/or alcohol screen.
  • Use of prescription or non-prescription drugs, including antacids, vitamins, herbal and dietary supplements (including St John's Wort and iron supplements) 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 sponsor the medication will not interfere with the study procedures or compromise subject safety.
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin values greater than the upper limit of normal. A single repeat is allowed for eligibility determination.
  • History of significant renal or hepatic diseases.
  • Any symptomatic arrhythmia (except isolated extra systoles).
  • Sustained cardiac arrhythmias (such as atrial fibrillation or flutter, supraventricular tachycardia (>/10 consecutive beats), complete heart block).
  • Non-sustained or sustained ventricular tachycardia (defined as >/ 3 consecutive ventricular ectopic beats).
  • Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular (AV) block [2nd degree or higher], WPW syndrome etc.).
  • Sinus Pauses > 3 seconds.
  • 300 or more supraventricular ectopic beats in 24 hours.
  • 250 or more ventricular ectopic beats in 24 hours.
  • An HIV-infected subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • An active Center for Disease Control (CDC) Category C disease [see Appendix 6], except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial.
  • Prior treatment with an integrase inhibitor (>/ 1 dose).
  • Serum alanine aminotransferase (ALT) >2 times the upper limit of normal at screening. A single repeat is allowed for eligibility determination.
  • Absolute neutrophil counts <1000/uL, hemoglobin <10 g/dL, platelet count <50,000/uL or creatinine clearance <50 mL/minute. A single repeat is allowed for eligibility determination.
  • History of clinically relevant pancreatitis or hepatitis within the previous 6 months.
  • Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 30 days of study drug administration or anticipated need for such treatment within the study.
  • Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 30 days of study drug administration
  • Treatment with any vaccine within 30 days prior to receiving study medication.
  • The subject has a positive pre-study drug screen including amphetamines, barbiturates, cocaine, or PCP.
  • Use of multivitamins or antacids within 7 days prior to the first dose of investigational product.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • GSK Investigational Site

    Charlotte, North Carolina, 28209

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33306

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33316

  • GSK Investigational Site

    Madison, Wisconsin, 53704

  • GSK Investigational Site

    Orlando, Florida, 32804

Other trials in United States

About this study

Official title: A Double-Blind, Parallel, Randomized, Placebo-Controlled, Single and Repeat Dose Escalation First Time in Human Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK1265744 in Healthy Male and Female Subjects and Subjects Infected With HIV

This study is a Phase I single and repeat dose escalation study of GSK1265744 in healthy subjects and a single repeat dose cohort in HIV-1 infected subjects. The study is planned to consist of three parts. Part A will enroll two cohorts with a total of 18 subjects in a single dose escalation to evaluate safety, tolerability and PK. Part B plans to enroll three cohorts of 10 subjects to evaluate repeat doses of GSK126744 on safety, tolerability and PK. Part A and B will enroll healthy volunteers. Part C will enroll HIV-1 patients in a single cohort of 10 subjects. This cohort will evaluate the effects of repeat dose on safety, tolerability, PK and efficacy.

Conditions
HIV Infection
Being tested
GSK1265744
Keywords
Healthy volunteer,, HIV infected subjects
Medical subject headings
HIV Infections

What participants receive

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

  • GSK1265744Drug

What is being measured

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

  1. Safety evaluations (labs, ECG, blood pressure), and blood sampling for PK, Continuous AE monitoring through study conclusion and follow up, 7-14 days after last dose. For Part C only: anti-viral activity through study conclusion and follow-up.

    Measured: through study conclusion and follow up, 7-14 days after last dose

Secondary outcomes (3)

  1. GSK1265744 blood levels to determine PK parameters

    Measured: on days 1 through day 10

  2. Plasma HIV-1 RNA levels

    Measured: from baseline and at intervals to Day 21

  3. To assess the development of genotypic viral resistance, if appropriate, in HIV cohort.

Timeline

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

  1. First posted16 Apr 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionNov 2008
  4. Study completionNov 2008

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00659191
Sponsor's protocol ID
111451
Status last verified
Oct 2010
First submitted
10 Apr 2008
Last updated
15 Oct 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK1265744 in people with HIV Infection, run by GlaxoSmithKline at 5 sites 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 10 inclusion and 44 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 15 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

Safety evaluations (labs, ECG, blood pressure), and blood sampling for PK, Continuous AE monitoring through study conclusion and follow up, 7-14 days after last dose. For Part C only: anti-viral activity through study conclusion and follow-up. (time frame: through study conclusion and follow up, 7-14 days after last dose). 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 NCT00659191.

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 15 Oct 2010.

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