HIV PreventionPhase 4RAL-NPEPNCT01087840
Raltegravir Use as Nonoccupational Postexposure Prophylaxis (NPEP) in Men Who Have Sex With Men
A Phase 4 study testing Raltegravir in people with HIV Prevention and HIV Infections, run by Andrew Carr at 2 sites in Australia.
Trial summary
The use of anti-HIV drugs following a potential sexual or injecting drug use exposure to HIV in order to try and prevent an exposure from becoming an infection is common. This is called nonoccupational postexposure prophylaxis (NPEP). Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- HIV Prevention, HIV Infections
- What is being tested?
- Raltegravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesAustralia
- Study dates
- Jul 2010to Jul 2012
- Phase
- Phase 4
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible MSM who, according to Australian NPEP guidelines, or in the opinion of the investigators, are assessed as eligible for NPEP following a potential or actual sexual exposure to HIV who present to St. Vincent's Hospital, Sydney.
Who cannot join
- Non sexual exposures
- Exposures occurring during sex between a man and a woman
- HIV infection diagnosed on baseline serological testing including indeterminate serology consistent with possible primary HIV infection
- Use of any medication contraindicated with RAL or TVD
- Serum hepatic transaminases (ALT/AST) greater than 5 times the upper limit of normal
- Serum creatinine greater than 2 times the upper limit of normal#
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- Therapy with adefovir, tenofovir, emtricitabine, lamivudine, or entecavir for hepatitis B
- Baseline serological evidence of chronic/active hepatitis B
- Previous NPEP containing RAL in the study period
- A patient with a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Sydney Sexual Health, Sydney Hospital
Sydney, New South Wales, 2000
St. Vincent's Hospital, 390 Victoria Rd, Darlinghurst
Sydney, New South Wales, 2010
About this study
Official title: Safety, Tolerability, and Adherence to a Raltegravir-based Antiretroviral Regimen for HIV Non-occupational Postexposure Prophylaxis
The use of anti-HIV drugs following a potential sexual or injecting drug use exposure to HIV in order to try and prevent an exposure from becoming an infection is common. This is called nonoccupational postexposure prophylaxis (NPEP). The likelihood of NPEP succeeding is related to intrinsic qualities of the drugs used which includes at which point in the life cycle of the HIV virus the drugs work, how strong the drugs are against HIV, and how well tolerated the drugs are i.e. what side effects they produce. Many people skip doses during their treatment or abandon their treatment because of side effects. The anti-HIV drug raltegravir works early in the life cycle of the virus i.e. before it integrates with human DNA, is potent against HIV and causes few side effects. These qualities make it an obvious choice for use as a NPEP treatment. In this study 100 HIV negative men will receive raltegravir along with another HIV drug called truvada (commonly used in NPEP) for 28 days after a possible sexual exposure to HIV. They will be monitored closely for adverse events, side effects and for their ability to take the medicine each day for the whole 28 days. The hypothesis in this study states that raltegravir use in NPEP will be safe, well tolerated and result in a high treatment completion rate.
Read the detailed description
This is a single site, 72-week, prospective, open-label, non-randomized trial. One hundred and 50 (150) eligible participants will be assigned to receive RAL 400 mg BID along with tenofovir disoproxil fumarate/emtricitabine (TVD) 1 tablet once daily (3-drug NPEP) for 28-days or TVD 1 tablet once daily (2-drug NPEP) for 28-days according to established Australian guidelines for the use of 3 or 2-drug NPEP following a potential or actual sexual exposure to HIV in men who have sex with men (MSM).1 Based on hospital NPEP data over the past 2 years, it is anticipated that 100 MSM will receive 3-drug (RAL-TVD) NPEP and 50 will receive 2-drug (TVD) NPEP. Follow-up post NPEP is for 23 weeks i.e. to week 24 post exposure.
Primary study objectives:
To describe the safety of 28 days of nonoccupational post-exposure prophylaxis(NPEP) containing raltegravir (RAL) To describe the tolerability of 28 days of NPEP containing RAL To describe on-drug adherence and regimen completion rates of 28 days of NPEP containing RAL
Secondary study objectives:
To investigate whether or not receipt of NPEP decreases, increases or has no impact on HIV risk taking behaviour To describe the effects of RAL and tenofovir disoproxil fumarate/emtricitabine (TVD) on key inflammatory biomarkers in a subset of the main study population
- Conditions
- HIV Prevention, HIV Infections
- Being tested
- Raltegravir
- Keywords
- HIV, nonoccupational, postexposure, prophylaxis, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
Also called Isentress, Tenofovir disoproxil fumarate/emtricitabine
Drug: Raltegravir tablet 400mg is taken orally, twice daily with or without food for 28 days along with Tenofovir disoproxil fumarate/emtricitabine 300mg/200mg 1 tablet taken orally once daily with or without food for 28 days.
Arms: Raltegravir/Truvada Other Names: Isentress/Truvada
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir, NPEP | Experimental | Drug: Raltegravir Tablet 400mg taken orally, twice daily with or without food for 28 days along with Truvada 1 tablet taken orally daily for 28 days.
Arms: Raltegravir/Truvada Receives: Drug: Raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the safety of 28 days of nonoccupational post-exposure prophylaxis containing raltegravir
Objective AE and SAE data collection/grading utilising DAIDS data collection tool. Measurement of weight and vital signs, electrolytes, urea, creatinine, eGFR, inorganic phosphate, calcium, liver function, glucose, amylase, lipase, creatine kinase, lactate, urinalysis
Measured: 28 days on drug with 5 month follow-up
To describe the tolerability of 28 days of NPEP containing raltegravir
Subjective reporting of AEs with data collection/grading utilising DAIDS-AE
Measured: 28 days on-drug and 5 months follow-up
To describe on-drug adherence and regimen completion rates of 28 days of NPEP containing raltegravir
Adherence measurement by self report and pill count at 3 time points during the 28-days of NPEP
Measured: 28 days
Secondary outcomes (3)
To describe the context of the risk
Context of risk event described using directed questioning around pre determined variables
Measured: Baseline visit day 1 of NPEP
To investigate whether or not receipt of NPEP decreases, increases or has no impact on future HIV risk taking behaviour
Baseline data collection of HIV risk behaviour in 6 months preceeding NPEP. Repeat data collection at week 12 and week 24 post NPEP risk event. Data collected utilising assisted completion of HIV related behaviour questionaire.
Measured: Visit 2 (day 3-5 of study), visit 7 (day 82-84 of study) visit 9 (day 166-168 of study)
To describe the effects of raltegravir and truvada on key inflammatory biomarkers
Measurement of CR-P, D-Dimer, IL-6 on a subset of 50 patients receiving raltegravir/truvada NPEP and a subset of 25 patients receiving truvada alone as NPEP.
Measured: Day 1 and day 28 of NPEP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Carr
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Andrew Carr, St Vincent's Hospital
- Investigators
- Robert Fielden, RN, Principal investigator, St Vincent's Hospital, SydneyAnna McNulty, MBBS, FAChSHM, Principal investigator, Sydney Sexual Health, Sydney HospitalPhillip Read, MBBS, FAChSHM, Principal investigator, Sydney Sexual Health, Sydney HospitalAndrew Carr, MBBS, MD, Principal investigator, St Vincents Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087840
- Sponsor's protocol ID
- RAL-NPEP version 1.
- Acronym
- RAL-NPEP
- Status last verified
- Apr 2014
- First submitted
- 15 Mar 2010
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
McAllister J, Carr A. Should a protease inhibitor be standard of care for HIV postexposure prophylaxis? AIDS. 2011 Mar 13;25(5):721-2. doi: 10.1097/QAD.0b013e32834168bd. No abstract available.
PubMed 21368592
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Adherence to a Raltegravir-based Antiretroviral Regimen for HIV Non-occupational Postexposure Prophylaxis
- ClinicalTrials.gov ID
- NCT01087840
- Acronym / sponsor ID
- RAL-NPEP / RAL-NPEP version 1.
- Conditions
- HIV Prevention, HIV Infections
- Keywords
- HIV, nonoccupational, postexposure, prophylaxis, HIV Seronegativity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Andrew CarrUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of anti-HIV drugs following a potential sexual or injecting drug use exposure to HIV in order to try and prevent an exposure from becoming an infection is common. This is called nonoccupational postexposure prophylaxis (NPEP). The likelihood of NPEP succeeding is related to intrinsic qualities of the drugs used which includes at which point in the life cycle of the HIV virus the drugs work, how strong the drugs are against HIV, and how well tolerated the drugs are i.e. what side effects they produce. Many people skip doses during their treatment or abandon their treatment because of side effects. The anti-HIV drug raltegravir works early in the life cycle of the virus i.e. before it integrates with human DNA, is potent against HIV and causes few side effects. These qualities make it an obvious choice for use as a NPEP treatment. In this study 100 HIV negative men will receive raltegravir along with another HIV drug called truvada (commonly used in NPEP) for 28 days after a possible sexual exposure to HIV. They will be monitored closely for adverse events, side effects and for their ability to take the medicine each day for the whole 28 days. The hypothesis in this study states that raltegravir use in NPEP will be safe, well tolerated and result in a high treatment completion rate.
Detailed description
This is a single site, 72-week, prospective, open-label, non-randomized trial. One hundred and 50 (150) eligible participants will be assigned to receive RAL 400 mg BID along with tenofovir disoproxil fumarate/emtricitabine (TVD) 1 tablet once daily (3-drug NPEP) for 28-days or TVD 1 tablet once daily (2-drug NPEP) for 28-days according to established Australian guidelines for the use of 3 or 2-drug NPEP following a potential or actual sexual exposure to HIV in men who have sex with men (MSM).1 Based on hospital NPEP data over the past 2 years, it is anticipated that 100 MSM will receive 3-drug (RAL-TVD) NPEP and 50 will receive 2-drug (TVD) NPEP. Follow-up post NPEP is for 23 weeks i.e. to week 24 post exposure.
Primary study objectives:
To describe the safety of 28 days of nonoccupational post-exposure prophylaxis(NPEP) containing raltegravir (RAL) To describe the tolerability of 28 days of NPEP containing RAL To describe on-drug adherence and regimen completion rates of 28 days of NPEP containing RAL
Secondary study objectives:
To investigate whether or not receipt of NPEP decreases, increases or has no impact on HIV risk taking behaviour To describe the effects of RAL and tenofovir disoproxil fumarate/emtricitabine (TVD) on key inflammatory biomarkers in a subset of the main study population
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raltegravir, NPEP | Experimental | Drug: RaltegravirDrug: Raltegravir Tablet 400mg taken orally, twice daily with or without food for 28 days along with Truvada 1 tablet taken orally daily for 28 days. Arms: Raltegravir/Truvada |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible MSM who, according to Australian NPEP guidelines, or in the opinion of the investigators, are assessed as eligible for NPEP following a potential or actual sexual exposure to HIV who present to St. Vincent's Hospital, Sydney.
Key exclusion criteria (10 listed)
- Non sexual exposures
- Exposures occurring during sex between a man and a woman
- HIV infection diagnosed on baseline serological testing including indeterminate serology consistent with possible primary HIV infection
- Use of any medication contraindicated with RAL or TVD
- Serum hepatic transaminases (ALT/AST) greater than 5 times the upper limit of normal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RaltegravirAlso: Isentress, Tenofovir disoproxil fumarate/emtricitabineDrug: Raltegravir tablet 400mg is taken orally, twice daily with or without food for 28 days along with Tenofovir disoproxil fumarate/emtricitabine 300mg/200mg 1 tablet taken orally once daily with or without food for 28 days. Arms: Raltegravir/Truvada Other Names: Isentress/Truvada | Drug | Raltegravir, NPEP |
Primary outcome
To describe the safety of 28 days of nonoccupational post-exposure prophylaxis containing raltegravir
Time frame: 28 days on drug with 5 month follow-up
Objective AE and SAE data collection/grading utilising DAIDS data collection tool. Measurement of weight and vital signs, electrolytes, urea, creatinine, eGFR, inorganic phosphate, calcium, liver function, glucose, amylase, lipase, creatine kinase, lactate, urinalysis
To describe the tolerability of 28 days of NPEP containing raltegravir
Time frame: 28 days on-drug and 5 months follow-up
Subjective reporting of AEs with data collection/grading utilising DAIDS-AE
To describe on-drug adherence and regimen completion rates of 28 days of NPEP containing raltegravir
Time frame: 28 days
Adherence measurement by self report and pill count at 3 time points during the 28-days of NPEP
3 secondary outcomes
To describe the context of the risk
Time frame: Baseline visit day 1 of NPEP
To investigate whether or not receipt of NPEP decreases, increases or has no impact on future HIV risk taking behaviour
Time frame: Visit 2 (day 3-5 of study), visit 7 (day 82-84 of study) visit 9 (day 166-168 of study)
To describe the effects of raltegravir and truvada on key inflammatory biomarkers
Time frame: Day 1 and day 28 of NPEP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
- Derived from this study: PubMed 21368592McAllister J, Carr A. Should a protease inhibitor be standard of care for HIV postexposure prophylaxis? AIDS. 2011 Mar 13;25(5):721-2. doi: 10.1097/QAD.0b013e32834168bd. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Fielden, RN principal investigator
St Vincent's Hospital, Sydney
Anna McNulty, MBBS, FAChSHM principal investigator
Sydney Sexual Health, Sydney Hospital
Phillip Read, MBBS, FAChSHM principal investigator
Sydney Sexual Health, Sydney Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Raltegravir in people with HIV Prevention and HIV Infections, run by Andrew Carr at 2 sites in Australia.
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 1 inclusion and 10 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: finished, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To describe the safety of 28 days of nonoccupational post-exposure prophylaxis containing raltegravir (time frame: 28 days on drug with 5 month follow-up). The study lists 3 primary outcomes in all. 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 NCT01087840, which also lists 1 linked publication.
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 17 Apr 2014.