Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women
This study has been completed.
Sponsor:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00745368
First Posted: September 3, 2008
Last Update Posted: October 10, 2012
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Robert Dicenzo, University of Rochester
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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: | Intervention Model: Single Group Assignment Masking: None (Open Label) |
| Official Title: | Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women |
Resource links provided by NLM:
Further study details as provided by Robert Dicenzo, University of Rochester:
Primary Outcome Measures:
- Raltegravir Male Genital Tract Concentration [ Time Frame: 8-10 hours after raltegravir dose ]
- Raltegravir Female Genital Tract Concentration [ Time Frame: 8-10 hours after raltegravir dose ]
- Male Paired Plasma Concentration [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 8-10 hours after raltegravir dose ]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
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745368
Locations
| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
Sponsors and Collaborators
University of Rochester
Merck Sharp & Dohme Corp.
More Information
| Responsible Party: | Robert Dicenzo, Adjunct Assistant Professor of Medicine, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00745368 History of Changes |
| Other Study ID Numbers: |
33113 |
| First Submitted: | September 1, 2008 |
| First Posted: | September 3, 2008 |
| Results First Submitted: | July 25, 2012 |
| Results First Posted: | October 10, 2012 |
| Last Update Posted: | October 10, 2012 |
| Last Verified: | September 2012 |
Keywords provided by Robert Dicenzo, University of Rochester:
|
HIV Raltegravir pharmacokinetics Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |