N/A
N=19
Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00745368 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Raltegravir Male Genital Tract Concentration — 485.1 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Raltegravir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Raltegravir Male Genital Tract Concentration |
485.1 | — |
| PRIMARY Raltegravir Female Genital Tract Concentration |
879.1 | — |
| PRIMARY Male Paired Plasma Concentration |
172 | — |
| PRIMARY Female Paired Plasma Concentration |
264.6 | — |
| PRIMARY Male Time Since Last Dose |
8.0 | — |
| PRIMARY Female Time Since Last Dose |
8.5 | — |
| PRIMARY Male Genital Tract:Plasma Concentration Ratio |
4.3 | — |
| PRIMARY Female Genital Tract:Plasma Concentration Ratio |
2.2 | — |
Summary
The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.
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
Data sourced from ClinicalTrials.gov (NCT00745368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.