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

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ClinicalTrials.gov Identifier: NCT00745368
Recruitment Status : Completed
First Posted : September 3, 2008
Results First Posted : October 10, 2012
Last Update Posted : October 10, 2012
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Robert Dicenzo, University of Rochester

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

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Raltegravir Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women
Study Start Date : September 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Raltegravir
Raltegravir 400 mg tablets twice daily
 Drug: Raltegravir
400 mg tablets twice daily during duration of trial


Outcome Measures
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Primary Outcome Measures :
  1. Raltegravir Male Genital Tract Concentration [ Time Frame: 8-10 hours after raltegravir dose ]
  2. Raltegravir Female Genital Tract Concentration [ Time Frame: 8-10 hours after raltegravir dose ]
  3. Male Paired Plasma Concentration [ Time Frame: 8-10 hours after raltegravir dose ]
    This sample was taken as close to the time of genital tract sample as possible

  4. Female Paired Plasma Concentration [ Time Frame: 8-10 hours after raltegravir dose ]
    This sample was taken as close to the time of genital tract sample as possible

  5. Male Time Since Last Dose [ Time Frame: 8-10 hours after raltegravir dose ]
    This measure describes the amount of time that expired between when the dose was administered and when the sample was taken

  6. Female Time Since Last Dose [ Time Frame: 8-10 hours after raltegravir dose ]
    This measure describes the amount of time that expired between when the dose was administered and when the sample was taken

  7. Male Genital Tract:Plasma Concentration Ratio [ Time Frame: 8-10 hours after raltegravir dose ]
    Units of raltegravir concentration for genital tract and plasma sample are ng/mL

  8. Female Genital Tract:Plasma Concentration Ratio [ Time Frame: 8-10 hours after raltegravir dose ]
    Units of raltegravir concentration for genital tract and plasma sample are ng/mL


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Robert Dicenzo, Adjunct Assistant Professor of Medicine, University of Rochester
ClinicalTrials.gov Identifier: NCT00745368     History of Changes
Other Study ID Numbers: 33113
First Posted: September 3, 2008    Key Record Dates
Results First Posted: October 10, 2012
Last Update Posted: October 10, 2012
Last Verified: September 2012

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action