HIV MedDRA version: 17.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Celsentri
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Maraviroc
CAS Number: 376348-65-1
Concentration unit:
Sponsors
Guy's & St. Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The ability to understand and sign a written informed consent form prior to participation in any screening procedures and must be willing to comply with all trial requirements. 2. Male or non-pregnant, non-lactating females 3. Age between 18 to 50 years, inclusive. 4. Body Mass Index (BMI) of 16 to 35 kg/m2, inclusive. 5. Negative antibody/antigen combined test for HIV-1 and HIV-2. 6. Absence of any significant health problems (in the opinion of the investigator) on the basis of the screening procedures; including medical history, physical examination, vital signs. 7. Willing to consent to their personal details being entered on to The Overvolunteering Prevention Scheme (TOPS) database. 8. Women participating in sexual intercourse that could result in pregnancy must use an adequate form of contraception throughout the study and for two weeks after the study. This includes intrauterine device, condoms, anatomical sterility in self or partner . Oral hormonal methods and implant contraceptives are allowed but only in combination with the additional protection of a barrier method. 9. Female participants may not use any vaginal products or objects or have vaginal sex for 48 hours before and after the collection of vaginal fluid and vaginal biopsies. This list includes tampons, female condoms, cotton wool, rags, diaphragms, cervical caps (or any other vaginal barrier method),douches, lubricants, vibrators/dildos, and drying agents. 10. Males participating in sexual intercourse that could result in pregnancy must use condoms during the duration of the study. 11. Men cannot use anal products or objects including but not exclusive to douches, lubricants and vibrators/dildos, butt plugs or urethral sounds or have receptive anal intercourse for 48 hours before and after the collection of rectal fluid and rectal biopsies. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 54 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Any significant acute or chronic medical illness as determined by the investigator.. 2. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs or clinical laboratory determinations. 3. Positive blood screen for syphilis, hepatitis B (HBs Ag) and/or C antibodies. 4. Positive blood screen for HIV-1 and/or HIV-2 antibodies by 4th generation assay. 5. Positive screen for sexually transmitted infections at screening visit 6. High-risk behaviour for HIV-1 infection which is defined as having one of the following within three months before trial day 0 (first dose): i. had unprotected vaginal or anal sex with a known HIV-1 infected person or a casual partner. ii. engaged in sex work for money or drugs. iii. acquired a bacterial sexually transmitted disease. iv. having a known HIV-1 positive partner either currently or in the previous six months 7. Females who are pregnant or breast-feeding. 8. Clinically significant laboratory abnormalities 9. Known hypersensitivity to peanut or soya, to the active substance or any of the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Samples are taken to evaluate this endpoint at different time points for each arm of the study as follows (each participant has 2 sampling time points in total - one after each of the 2 doses of IMP): Arm B: 1st sampling 2 hours post 1st Maraviroc 300g stat dose 2nd sampling 24 hours post 2nd Maraviroc 300mg stat dose Arm C: 1st sampling 4 hours post 1st Maraviroc 300g stat dose 2nd sampling 36 hours post 2nd Maraviroc 300mg stat dose Arm D: 1st sampling 6 hours post 1st Maraviroc 300mg stat dose 2nd sampling 48 hours post 2nd Maraviroc 300mg stat dose Arm E: 1st sampling 12 hours post 1st Maraviroc 300mg stat dose 2nd sampling 72 hours post 2nd Maraviroc 300mg stat dose ; Main Objective: To determine concentration of Maraviroc in directly aspirated fluid and tissue from the genital tract and rectal compartments at different time periods following a single oral administration of Maraviroc 300mg in HIV-1-negative healthy volunteers ; Secondary Objective: To determine the level of Maraviroc required in the plasma, vagina, rectum and urethra for 100% ex-vivo protection from HIV-1 To determine the safety and tolerability of Maraviroc 300mg in HIV-1 negative individuals administered in a single dose ;Primary end point(s): Concentration of Maraviroc in fluid and tissue from the genital tract and rectal compartments at different time periods following a single oral administration of Maraviroc 300mg in HIV-1-negative healthy volunteers. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Level of Maraviroc required in the plasma, vagina, rectum and urethra for 100% ex vivo protection from HIV-1 A comparison of measuring Maraviroc drug levels by either Weck cell sponge and rovumeters ;Timepoint(s) of evaluation of this end point: Samples taken as above for primary endpoint and are then sent to the lab for quantification of protection from HIV-1 infection | — |
Countries
United Kingdom
Contacts
Public ContactDr Julie Fox
Guy's & St. Thomas' NHS Foundation Trust
Outcome results
None listed