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

September 1, 2008
September 7, 2012
September 2008
June 2011   (final data collection date for primary outcome measure)
  • 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
Raltegravir genital tract concentration [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00745368 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women
Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women

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

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.

Interventional
Not Provided
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
HIV Infections
Drug: Raltegravir
400 mg tablets twice daily during duration of trial
Experimental: Raltegravir
Raltegravir 400 mg tablets twice daily
Intervention: Drug: Raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00745368
33113
No
Robert Dicenzo, University of Rochester
University of Rochester
Merck Sharp & Dohme Corp.
Not Provided
University of Rochester
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP