N/A
Completed N=16
Concentrations of Raltegravir in the Semen of HIV-Infected Men
Source: ClinicalTrials.gov NCT01045265 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Seminal Concentrations of Raltegravir. — 0.18; 1.91 mg/l
Summary
The objective of this study is to determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dose interval.
The secondary objective is to determine the extend of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval, to determine the area under the concentration time curve of raltegravir in semen, and to determine the variability in the penetration of raltegravir into the seminal compartment over the dosing period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seminal Concentrations of Raltegravir. |
0.18; 1.91 | — |
| SECONDARY Semen to Plasma Raltegravir Concentrations |
3.25 | — |
| SECONDARY Seminal Distribution of Raltegravir |
6.83 | — |
| SECONDARY Semen to Plasma Distribution of Raltegravir |
2.26 | — |
Eligibility Criteria
Inclusion Criteria
- HIV infected male
- 18 years old or older
- on raltegravir twice daily as part of their antiretroviral regimen for at least 3 months prior to screening
- viral load 3 times the upper limit of normal
- serum creatinine > 1.5 times upper limit of normal
- patient receiving concomitant therapy with rifampin or St. John's wort
Data sourced from ClinicalTrials.gov (NCT01045265). 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. Informational only — not medical advice.