AzTrials
AzTrials

HIV InfectionsPhase 1/2NCT01049932

Pre-Exposure Prophylaxis Using TMC278LA

A Phase 1/2 study testing TMC278LA in people with HIV Infections, run by St Stephens Aids Trust at 4 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
TMC278LA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
4 sitesUnited Kingdom
Study dates
Mar 2010to May 2010
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects must meet all of the following inclusion criteria within 42 days prior to the baseline visit:
  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
  • 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):
Show all 14Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

United Kingdom4 sites

  • Royal Sussex County Hospital

    Brighton, Sussex, BN2 5BE

  • St. Thomas's Hospital

    London, SE1 7EH

  • St Stephen's Centre

    London, SW10 9TH

  • St. Mary's Hospital

    London, W2 1NY

Other trials in United Kingdom

About this study

Official title: PrEP TMC278LA: Safety, Tolerability and Pharmacokinetics of TMC278LA in HIV Negative Volunteers

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.

Read the detailed description

While for certain diseases, the use of medications by healthy people has been proven to function as prophylaxis, i.e. malaria, it is still unknown whether PrEP can help prevent HIV infection from exposure during sex or injection-drug use.

To address whether PrEP is safe and effective for use in humans, the traditional sequence of drug development steps should be followed as closely as possible.

TMC278 (rilpivirine) is a new investigational non nucleoside reverse transcriptase inhibitor (NNRTI) discovered and in development by Tibotec, a division of Johnson \& Johnson. Data from clinical development (Phase IIB) suggest that TMC278 has a similar efficacy and better side-effect profile as compared to other, older, NNRTIs, such as efavirenz. Like TMC125 (etravirine), TMC278 is a diarylpyrimidine (DAPY - a class of molecule that resembles the pyrimidine nucleotides found in DNA, and which have shown potency in inhibiting the activity of HIV reverse transcriptase).

Tibotec is currently investigating TMC278 in two formulations: an oral formulation for HIV treatment and, in early phase, a long acting (LA) injectable formulation for HIV treatment. The latter has also potential application for HIV transmission prevention.

TMC278LA is an innovative drug formulation and its long apparent half life may allow administration of PrEP monthly rather than orally and daily, as for other ARV that are currently studied as PrEP agents.

Therefore, a phase I/II, open-label, prospective, single arm, pharmacokinetic clinical trial in 100 HIV negative subjects (50% of whom will have to be of self-identified African ancestry and 50% females, approximately) is to be conducted. The study will examine whether a monthly dose of TMC278LA not exceeding 600 mg i/m over a time period of approximately six months, with a loading regimen of the first two i/m injections separated by two weeks, is safe and well tolerated by HIV-negative subjects.

Investigation of drug pharmacokinetics in plasma and genital secretions will be also carried out in order to ensure optimal drug exposure during drug administration.

100 evaluable subjects will be enrolled, with approximately 50 of African ancestry, and 50 females. This will provide 50-subject-years of safety data in order to support a later large phase III global efficacy study.

Conditions
HIV Infections
Being tested
TMC278LA
Keywords
HIV, Human Immunodeficiency Virus (HIV), HIV Seronegativity
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TMC278LADrug

    Also called Rilpivirine

    TMC278LA 600mg injected intramuscularly (i/m)

Study groups in NCT01049932
Study groupRoleWhat they receive
All subjectsExperimentalTMC278LA 600mg injected intramuscularly (i/m)
Receives: Drug: TMC278LA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 217 ± 10 days

Secondary outcomes (2)

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

    Measured: 217 ± 10 days

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

    Measured: 217 ± 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionMay 2010
  4. Study completionMay 2010

Why it stopped: Trial closed due to additional safety information.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01049932
Sponsor's protocol ID
SSAT 037
Other IDs
EudraCT: 2009-017631-17
Status last verified
Aug 2010
First submitted
11 Jan 2010
Last updated
16 Aug 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TMC278LA in people with HIV Infections, run by St Stephens Aids Trust at 4 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Trial closed due to additional safety information.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 217 ± 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01049932.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Pre-Exposure Prophylaxis Using TMC278LA (NCT01049932) | AzTrials