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

NCT ID: NCT00745368

Last Updated: 2012-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-06-30

Brief Summary

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

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.

Conditions

HIV Infections

Keywords

HIV; Raltegravir; pharmacokinetics; Treatment Experienced

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Raltegravir

Raltegravir 400 mg tablets twice daily

Group Type: EXPERIMENTAL

Raltegravir

Intervention Type: DRUG

400 mg tablets twice daily during duration of trial

Interventions

Raltegravir

400 mg tablets twice daily during duration of trial

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Robert Dicenzo

Adjunct Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

33113

Identifier Type: -

Identifier Source: org_study_id