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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00745368

Enrollment

Registered

2008-09-03

Start date

2008-09-30

Completion date

2011-06-30

Last updated

2012-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, Raltegravir, pharmacokinetics, Treatment Experienced

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.

Interventions

DRUGRaltegravir

400 mg tablets twice daily during duration of trial

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Raltegravir Male Genital Tract Concentration	8-10 hours after raltegravir dose	—
Raltegravir Female Genital Tract Concentration	8-10 hours after raltegravir dose	—
Male Paired Plasma Concentration	8-10 hours after raltegravir dose	This sample was taken as close to the time of genital tract sample as possible
Female Paired Plasma Concentration	8-10 hours after raltegravir dose	This sample was taken as close to the time of genital tract sample as possible
Male Time Since Last Dose	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
Female Time Since Last Dose	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
Male Genital Tract:Plasma Concentration Ratio	8-10 hours after raltegravir dose	Units of raltegravir concentration for genital tract and plasma sample are ng/mL
Female Genital Tract:Plasma Concentration Ratio	8-10 hours after raltegravir dose	Units of raltegravir concentration for genital tract and plasma sample are ng/mL

Countries

United States

Participant flow

Participants by arm

Arm	Count
Raltegravir Raltegravir 400 mg tablets twice daily	16
Total	16

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Unable to provide sample	3

Baseline characteristics

Characteristic	Raltegravir
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	16 Participants
Age Continuous	47 years STANDARD_DEVIATION 8.8
Region of Enrollment United States	16 participants
Sex: Female, Male Female	8 Participants
Sex: Female, Male Male	8 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 16
serious Total, serious adverse events	0 / 16