Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Robert Dicenzo, University of Rochester
ClinicalTrials.gov Identifier:
NCT00745368
First received: September 1, 2008
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.


Condition Intervention
HIV Infections
Drug: Raltegravir

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Raltegravir Male Genital Tract Concentration [ Time Frame: 8-10 hours after raltegravir dose ] [ Designated as safety issue: No ]
  • Raltegravir Female Genital Tract Concentration [ Time Frame: 8-10 hours after raltegravir dose ] [ Designated as safety issue: No ]
  • Male Paired Plasma Concentration [ Time Frame: 8-10 hours after raltegravir dose ] [ Designated as safety issue: No ]
    This sample was taken as close to the time of genital tract sample as possible

  • Female Paired Plasma Concentration [ Time Frame: 8-10 hours after raltegravir dose ] [ Designated as safety issue: No ]
    This sample was taken as close to the time of genital tract sample as possible

  • Male Time Since Last Dose [ Time Frame: 8-10 hours after raltegravir dose ] [ Designated as safety issue: No ]
    This measure describes the amount of time that expired between when the dose was administered and when the sample was taken

  • Female Time Since Last Dose [ Time Frame: 8-10 hours after raltegravir dose ] [ Designated as safety issue: No ]
    This measure describes the amount of time that expired between when the dose was administered and when the sample was taken

  • Male Genital Tract:Plasma Concentration Ratio [ Time Frame: 8-10 hours after raltegravir dose ] [ Designated as safety issue: No ]
    Units of raltegravir concentration for genital tract and plasma sample are ng/mL

  • Female Genital Tract:Plasma Concentration Ratio [ Time Frame: 8-10 hours after raltegravir dose ] [ Designated as safety issue: No ]
    Units of raltegravir concentration for genital tract and plasma sample are ng/mL


Enrollment: 28
Study Start Date: September 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Raltegravir
Raltegravir 400 mg tablets twice daily
Drug: Raltegravir
400 mg tablets twice daily during duration of trial

Detailed Description:

Although we have many medications to fight the HIV virus, very little is known about how much of these medications get into the genital tract. Raltegravir is a new HIV medication that blocks HIV growth and lowers the amount of virus in the blood in a way that is different than all other currently available HIV medications. Raltegravir was recently approved by the Food and Drug Administration (FDA) for use in HIV infected patients, but there is very little information concerning how much raltegravir will reach the genital tract of men or women. The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documentation of blood seropositive for HIV based on self report and confirmed by ELISA and Western blot or detectable HIV RNA

    • Stable anti-retroviral regimen for at least 3 weeks prior to enrollment
    • Capable of giving informed consent
    • Age 18 years and older

Exclusion Criteria:

  • Neoplasms
  • Women who are pregnant or nursing
  • History or current evidence of any significant acute or chronic medical illness that in the opinion of the investigator would preclude the subject from safely participating in the study
  • Current use of phenobarbital, phenytoin, or rifampin
  • Any major surgery within 4 weeks of enrollment
  • Blood transfusion within 4 weeks of enrollment
  • Inability to tolerate oral medication
  • Inability to tolerate venipuncture, venous access, or genital tract sampling
  • History of recent (within 6 months) drug or alcohol abuse
  • Evidence of organ dysfunction or any clinically significant deviation from normal in the medical history, physical examination, vital signs, and or clinical laboratory determinations that in the opinion of the investigator would preclude the subject from safely participating in the study
  • Any other sound medical, psychiatric and or social reason for exclusion as determined by the investigator
  • History of allergy to study medication or related compounds
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00745368

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Robert Dicenzo, Adjunct Assistant Professor of Medicine, University of Rochester
ClinicalTrials.gov Identifier: NCT00745368     History of Changes
Other Study ID Numbers: 33113
Study First Received: September 1, 2008
Results First Received: July 25, 2012
Last Updated: September 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
HIV
Raltegravir
pharmacokinetics
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 22, 2014