The dose and genital tract concentration of Maraviroc needed for protection from HIV infectio

Phase 1

• Conditions: MedDRA version: 17.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862; HIV; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-003778-16-GB
• Lead Sponsor: Guy's & St. Thomas' NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-05
• Study Completion: 2015-07-01
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 58

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified