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

NCT00745368 | Completed Results

• 1 other identifier: 33113
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (8)

• 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

  This sample was taken as close to the time of genital tract sample as possible

  8-10 hours after raltegravir dose

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Raltegravir

EXPERIMENTAL

Raltegravir 400 mg tablets twice daily

Drug: Raltegravir

Interventions

Raltegravir DRUG

400 mg tablets twice daily during duration of trial

Raltegravir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• History of allergy to study medication or related compounds

Sponsors & Collaborators

• University of Rochester: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Due to limited sample size and large intersubject variability, more study comparing male and female GT concentrations is needed.

Results Point of Contact

• Title: Robert DiCenzo
• Organization: University of Rochester

rob.dicenzo@acphs.edu

518 694 7228

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor of Medicine

Study Record Dates

• First Submitted: September 1, 2008
• First Posted: September 3, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 10, 2012
• Results First Posted: October 10, 2012

Record last verified: 2012-09

Locations

US (1)