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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745368
• Other study ID #: 33113
• Status: Completed
• Phase: N/A
• First received: September 1, 2008
• Last updated: September 7, 2012
• Start date: September 2008
• Est. completion date: June 2011

Study information

• Verified date: September 2012
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Raltegravir
400 mg tablets twice daily during duration of trial

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Raltegravir Male Genital Tract Concentration		8-10 hours after raltegravir dose	No
Primary	Raltegravir Female Genital Tract Concentration		8-10 hours after raltegravir dose	No
Primary	Male Paired Plasma Concentration	This sample was taken as close to the time of genital tract sample as possible	8-10 hours after raltegravir dose	No
Primary	Female Paired Plasma Concentration	This sample was taken as close to the time of genital tract sample as possible	8-10 hours after raltegravir dose	No
Primary	Male Time Since Last Dose	This measure describes the amount of time that expired between when the dose was administered and when the sample was taken	8-10 hours after raltegravir dose	No
Primary	Female Time Since Last Dose	This measure describes the amount of time that expired between when the dose was administered and when the sample was taken	8-10 hours after raltegravir dose	No
Primary	Male Genital Tract:Plasma Concentration Ratio	Units of raltegravir concentration for genital tract and plasma sample are ng/mL	8-10 hours after raltegravir dose	No
Primary	Female Genital Tract:Plasma Concentration Ratio	Units of raltegravir concentration for genital tract and plasma sample are ng/mL	8-10 hours after raltegravir dose	No