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Comparing Raltegravir Genital Tract Distribution in HIV-Infected Men and Women
This study is currently recruiting participants.
Verified by University of Rochester, September 2008
First Received: September 1, 2008   Last Updated: October 8, 2008   History of Changes
Sponsor: University of Rochester
Collaborator: Merck
Information provided by: University of Rochester
ClinicalTrials.gov Identifier: NCT00745368
  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: Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
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 genital tract concentration [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2008
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

Contacts
Contact: Robert DiCenzo, Pharm.D. 585-451-2543 robert_dicenzo@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Robert DiCenzo, Pharm.D.     585-451-2543     robert_dicenzo@urmc.rochester.edu    
Principal Investigator: Robert DiCenzo, Pharm.D.            
Sub-Investigator: Amneris Luque, MD            
Sponsors and Collaborators
University of Rochester
Merck
  More Information

No publications provided

Responsible Party: University of Rochester ( Robert DiCenzo, Pharm.D. )
Study ID Numbers: 33113
Study First Received: September 1, 2008
Last Updated: October 8, 2008
ClinicalTrials.gov Identifier: NCT00745368     History of Changes
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on February 09, 2010