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

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Raltegravir Raltegravir potassium

U.S. FDA Resources

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

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 May 19, 2013