NCT01325051

Brief Summary

The purpose of this study is to characterize the way the first commercially available integrase inhibitor, raltegravir, a new class of antiretrovirals that is used to treat HIV, is distributed into the rectal mucosal tissue. This information will generate important information regarding the drug's penetration into lymphoid tissues that are rapidly depleted in HIV infection. Subsequently strategies to prevent the sexual transmission of HIV and for treating HIV-infected individuals will be designed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

7 months

First QC Date

March 23, 2011

Last Update Submit

January 3, 2012

Conditions

Healthy Volunteer

Keywords

raltegravirpharmacokineticshealthymalevolunteersgastrointestinaltract

Outcome Measures

Primary Outcomes (1)

  • AUC = Area under the concentration versus time curve of raltegravir

    0, 1, 2, 3, 4, 6, 8, and 12 hours after single dose (Day 1) and 0, 1, 2, 3, 4, 6, 8, and 12 hours after 13 doses (Day 7)

Secondary Outcomes (4)

  • Cmax = maximum concentration of raltegravir

    0, 1, 2, 3, 4, 6, 8, and 12 hours after single dose (Day 1) and 0, 1, 2, 3, 4, 6, 8, and 12 hours after 13 doses (Day 7)

  • Tmax = time to maximum concentration of raltegravir

    0, 1, 2, 3, 4, 6, 8, and 12 hours after single dose (Day 1) and 0, 1, 2, 3, 4, 6, 8, and 12 hours after 13 doses (Day 7)

  • C12 = concentration at 12 hours after dose of raltegravir

    0, 1, 2, 3, 4, 6, 8, and 12 hours after single dose (Day 1) and 0, 1, 2, 3, 4, 6, 8, and 12 hours after 13 doses (Day 7)

  • t1/2 = half-life of raltegravir

    0, 1, 2, 3, 4, 6, 8, and 12 hours after single dose (Day 1) and 0, 1, 2, 3, 4, 6, 8, and 12 hours after 13 doses (Day 7)

Study Arms (1)

Raltegravir

NO INTERVENTION

To test raltegravir to see if it can be detected in gastrointestinal tissue of healthy men.

Drug: Raltegravir

Interventions

RaltegravirDRUG

400 mg tablets by mouth BID from Day 1 - Day 7 after enrollment visit

Also known as: MK-0518, ISENTRESS
Raltegravir

Eligibility Criteria

Age18 Years - 49 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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, and clinical laboratory tests.
  • Body Mass Index (BMI) of approximately 18 to 30 kg/m\^2; and a total body weight greater than or equal to 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.

You may not qualify if:

  • \) any medical condition or finding deemed by the investigators to be ineligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (8)

  • Musicco M, Lazzarin A, Nicolosi A, Gasparini M, Costigliola P, Arici C, Saracco A. Antiretroviral treatment of men infected with human immunodeficiency virus type 1 reduces the incidence of heterosexual transmission. Italian Study Group on HIV Heterosexual Transmission. Arch Intern Med. 1994 Sep 12;154(17):1971-6.

    PMID: 8074601BACKGROUND

  • Otten RA, Smith DK, Adams DR, Pullium JK, Jackson E, Kim CN, Jaffe H, Janssen R, Butera S, Folks TM. Efficacy of postexposure prophylaxis after intravaginal exposure of pig-tailed macaques to a human-derived retrovirus (human immunodeficiency virus type 2). J Virol. 2000 Oct;74(20):9771-5. doi: 10.1128/jvi.74.20.9771-9775.2000.

    PMID: 11000253BACKGROUND

  • Lallemant M, Jourdain G, Le Coeur S, Mary JY, Ngo-Giang-Huong N, Koetsawang S, Kanshana S, McIntosh K, Thaineua V; Perinatal HIV Prevention Trial (Thailand) Investigators. Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand. N Engl J Med. 2004 Jul 15;351(3):217-28. doi: 10.1056/NEJMoa033500. Epub 2004 Jul 9.

    PMID: 15247338BACKGROUND

  • Blankson JN, Persaud D, Siliciano RF. The challenge of viral reservoirs in HIV-1 infection. Annu Rev Med. 2002;53:557-93. doi: 10.1146/annurev.med.53.082901.104024.

    PMID: 11818490BACKGROUND

  • Pierson T, Hoffman TL, Blankson J, Finzi D, Chadwick K, Margolick JB, Buck C, Siliciano JD, Doms RW, Siliciano RF. Characterization of chemokine receptor utilization of viruses in the latent reservoir for human immunodeficiency virus type 1. J Virol. 2000 Sep;74(17):7824-33. doi: 10.1128/jvi.74.17.7824-7833.2000.

    PMID: 10933689BACKGROUND

  • Isentress (raltegravir) Prescribing Guide. Merck & Co, Inc. October 2007.

    BACKGROUND

  • Markowitz M, Morales-Ramirez JO, Nguyen BY, Kovacs CM, Steigbigel RT, Cooper DA, Liporace R, Schwartz R, Isaacs R, Gilde LR, Wenning L, Zhao J, Teppler H. Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naive HIV-1-infected individuals. J Acquir Immune Defic Syndr. 2006 Dec 15;43(5):509-15. doi: 10.1097/QAI.0b013e31802b4956.

    PMID: 17133211BACKGROUND

  • Barau C, Delaugerre C, Braun J, de Castro N, Furlan V, Charreau I, Gerard L, Lascoux-Combe C, Molina JM, Taburet AM. High concentration of raltegravir in semen of HIV-infected men: results from a substudy of the EASIER-ANRS 138 trial. Antimicrob Agents Chemother. 2010 Feb;54(2):937-9. doi: 10.1128/AAC.01261-09. Epub 2009 Dec 7.

    PMID: 19995925BACKGROUND

MeSH Terms

Interventions

Raltegravir Potassium

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Angela Kashuba, PharmD

    UNC-CH School of Pharmacy

    PRINCIPAL INVESTIGATOR

  • Kristine Patterson, MD

    UNC-CH Division of Infectious Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 23, 2011

First Posted

March 29, 2011

Study Start

April 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

US(1)