HIV MedDRA version: 19.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Raltegravir
Product Name: Raltegravir
Pharmaceutical Form: Tablet
INN or Proposed INN: RALTEGRAVIR
CAS Number: 871038-72-1
Sponsors
Guy's and 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 60 years, inclusive. 4. Body Mass Index (BMI) of 16 to 35 kg/m2, inclusive. 5. Negative antibody/antigen combined test for HIV. 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. 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. 8. 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. 9. Males participating in sexual intercourse that could result in pregnancy must use condoms during the duration of the study. 10. Men and women 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 biopsies. 11. Willing to abstain from multivitamins and antacids for the study duration. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any significant acute or chronic medical illness. 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 antibodies. 5. Positive screen for sexually transmitted infections at screening visit 6. High-risk behaviour for HIV infection which is defined as having one of the following within three months before trial day 0 (first dose): had unprotected vaginal or anal sex with a known HIV infected person or a casual partner. engaged in sex work for money or drugs. acquired a bacterial sexually transmitted disease in the past 3 months. having a known HIV positive partner either currently or in the previous six months Females who are pregnant or breast-feeding. 7. Clinically significant laboratory abnormalities (according to normal range as defined by central laboratory). 8. Participation in a clinical trial of an Investigational product within 1 month of planned baseline enrolment in this study. 9. Ingestion of H2 receptor antagonists or proton pump inhibitor drugs in the preceding 14 days 10. Current of planned use of anti-epileptics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The level of Raltegravir alone or Raltegravir /lamivudine required in the plasma, vagina, rectum and urethra for ex vivo protection from HIV; Secondary Objective: 1. To determine the time from first dose of drug to mucosal ex vivo protection from HIV-1 infection 2. To determine the time to cessation of mucosal ex vivo protection from HIV-1 after stopping ART at steady state. 3. To determine the safety and tolerability of Raltegravir based PreP in HIV-1 negative individuals ;Primary end point(s): The level of Raltegravir alone or Raltegravir /lamivudine required in the plasma, vagina and rectum for ex vivo protection from HIV; Timepoint(s) of evaluation of this end point: A 1 & B 1 will have sampling visits on day 2 and 8 A 2 & B 2 will have sampling visits on day 4 and 10 A3 & B 3 will have sampling visits on day 6 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The time from first dose of drug to mucosal ex vivo protection from HIV infection 2. The time to cessation of mucosal ex vivo protection from HIV after stopping ART at steady state. 3. The safety and tolerability of Raltegravir based PreP in HIV negative individuals | — |
Countries
United Kingdom
Contacts
Public ContactDr Julie Fox
Guy's & St. Thomas' NHS Foundation Trust
Outcome results
None listed