Pre-Exposure Prophylaxis Using TMC278LA

NCT01049932 | Terminated Phase 1 DMC

• 2 other identifiers: SSAT 037EudraCT: 2009-017631-17
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

Pre-exposure prophylaxis (PrEP) is an experimental HIV-prevention strategy using antiretroviral (ARV) agents to protect HIV negative individuals from HIV infection.TMC278 is a new drug being developed for this type of HIV treatment. It is hoped that this drug may be used to help prevent HIV transmission in future. A 'long acting' formulation of TMC278 has been developed. Long acting means that the drug will be present in the blood for longer. It is this formulation of the drug that will be investigated in this study. Subjects will receive the drug by injection. The purpose of this study is to investigate the safety of the drug and how well it is tolerated by the body. The study will look at the levels of the study drug in the subjects blood over the duration of the study.

Conditions

HIV Infections

Keywords

HIV; Human Immunodeficiency Virus (HIV); HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• Local or systemic adverse events including local reactions to the IMP, all DAIDS (2004) grade ≥1 adverse events, serious adverse events (including laboratory abnormalities) and suspected unexpected serious adverse reactions (SUSARs)

  217 ± 10 days

Secondary Outcomes (2)

• Drug plasma pharmacokinetics following first i/m dose and at steady state

  217 ± 10 days

• Male and female genital tract drug concentrations following first i/m dose and at steady state

  217 ± 10 days

Study Arms (1)

All subjects

EXPERIMENTAL

TMC278LA 600mg injected intramuscularly (i/m)

Drug: TMC278LA

Interventions

TMC278LA DRUG

TMC278LA 600mg injected intramuscularly (i/m)

Also known as: Rilpivirine

All subjects

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must understand and sign a written informed consent form, prior to participation in any screening procedures and must comply with all study requirements
• Male or non-pregnant, non-lactating females of different ethnic backgrounds
• Age between 18 to 50 years, inclusive
• Body Mass Index (BMI) of 16 to 35 kg/m2, inclusive
• Absence of any significant health problems on the basis of the screening procedures; including medical history, physical examination, vital signs, ECG
• Clinically significant laboratory abnormalities
• Willing to undergo HIV testing, HIV discussion and receive HIV test results (according to the "UK National Guidelines for HIV Testing 2008", www.bhiva.org)
• Women of childbearing potential must be using an adequate method of contraception (diaphragm, intrauterine device, condoms, anatomical sterility in self or partner) to avoid pregnancy throughout the study and for a period of at least four months after the study follow up visit. Oral hormonal methods and implant contraceptives are allowed but only in combination with the additional protection of a barrier method
• If sexually active male, willing to use an effective method of contraception such as condoms, anatomical sterility from the day of enrolment until at least four months after the follow up visit
• Likely to remain resident in the UK for the duration of the study and follow-up period
• Willing to consent to their personal details being entered onto The Over volunteering Prevention Scheme (TOPS) database
• Willing to provide photographic identification at each visit.
• Registered with a GP in the UK

You may not qualify if:

• Any significant acute or chronic medical illness
• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
• Positive blood screen for syphilis, hepatitis A (IgM) B (HBs Ag) and/or C antibodies
• Positive blood screen for HIV-1 and/or HIV-2 antibodies
• High-risk behaviour for HIV infection which is defined as having one of the following within six months before study day 0 (first dose):
• i. had unprotected vaginal or anal sex with a known HIV infected person or a casual partner ii. engaged in sex work for money or drugs iii. acquired a sexually transmitted disease iv. having a high risk partner either currently or in the previous six months
• Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events
• Exposure to any investigational drug or placebo within 30 days of first dose of study drug (additional check to be made on TOPS www.tops.org.uk)
• History of severe drug allergy that the Investigator thinks may increase the risk of developing an allergic reaction to the study drug
• Use of any drug, including over-the-counter medications and herbal preparations, within two weeks prior to first dose of study drug unless approved by the Investigator
• Females who are pregnant or lactating
• Females of childbearing potential not using effective non-hormonal birth control methods, or not willing to practise these birth control methods for at least four months after the study follow up visit
• Males unwilling to use an effective method of contraception such as condoms, anatomical sterility from the day of enrolment until at least four months after the follow up visit

Sponsors & Collaborators

• St Stephens Aids Trust: lead

Study Sites (4)

Royal Sussex County Hospital

Brighton, Sussex, BN2 5BE, United Kingdom

Location

St. Thomas's Hospital

London, SE1 7EH, United Kingdom

Location

St Stephen's Centre

London, SW10 9TH, United Kingdom

Location

St. Mary's Hospital

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Rilpivirine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marta Boffito, Dr

  St Stephen's AIDS Trust (London)

  PRINCIPAL INVESTIGATOR

• Akil Jackson, Dr

  St Stephen's AIDS Trust (London)

  PRINCIPAL INVESTIGATOR

• Martin Fisher, Dr

  Royal Sussex County Hospital, Brighton

  PRINCIPAL INVESTIGATOR

• Alan Winston, Dr

  St Mary's Hospital, London

  PRINCIPAL INVESTIGATOR

• Julie Fox, Dr

  St. Thomas's Hospital (London)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 15, 2010
• Study Start: March 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 16, 2010

Record last verified: 2010-08

Locations

GB (4)