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Completed

NCT Number: NCT00745368

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

raltegravir

Drug

400 mg tablets twice daily during duration of trial

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 3, 2008
Registry last updated
Oct 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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