HIVPhase 3NCT01701882
A Pilot Study to Assess the Feasibility of Switching, Individuals Receiving Atripla With Continuing Central Nervous System (CNS) Toxicity, to a Fixed Dose Combination of Tenofovir/Emtricitabine/Rilpivirine
A Phase 3 study testing tenofovir/emtricitabine/rilpivirine in people with HIV, run by St Stephens Aids Trust at 1 site in United Kingdom.
Trial summary
The purpose of the study is to investigate the benefits of switching away from efavirenz (which patients are taking in combination with Kivexa® or as part of the combination pill, Atripla®) in patients with central nervous system side effects (such as insomnia {difficulty with sleeping}, bad dreams etc). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- tenofovir/emtricitabine/rilpivirine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Nov 2013
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient volunteers who meet all of the following criteria are eligible for this trial:
- Is male or female aged 18 years or above
- Has HIV-1 infection documented in their medical notes
- Has signed the Informed Consent Form voluntarily
- Is willing to comply with the protocol requirements
- Has been on Atripla for at least 12 weeks OR Kivexa plus efavirenz
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- Has an HIV-plasma viral load at screening <50 copies/mL (single re-test allowed)
- Has a CD4 cell count at screening >50 cells/mm3
- Estimated glomerular filtration rate (MDRD) >50 ml/min.
- Has symptomatic CNS related toxicity associated with EFV
- If female and of childbearing potential, is using effective birth control methods (as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 30 days after the end of the trial. Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential
- If a heterosexually active male, he is using effective birth control methods and is willing to continue practising these birth control methods during the trial and until follow-up visit
Who cannot join
- Patients meeting 1 or more of the following criteria cannot be selected:
- Infected with HIV-2
- Using any concomitant therapy disallowed as per SPC for the study drugs (note acid-reducing agents and interaction with rilpivirine)
- Has acute viral hepatitis including, but not limited to, A, B, or C
- Has chronic hepatitis B and/or C with AST and/or ALT >5 x ULN Note: Subjects can enter trial with chronic HBV if HBV-DNA undetectable at screen (and no detectable result in last 6 months) and with chronic HCV if not expected to require treatment during the trial period.
- Any investigational drug within 30 days prior to the trial drug administration
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- Has received rilpivirine in the past
- Any clinical evidence of baseline resistance mutations
- Known allergy to lactose monohydrate, sunset yellow aluminium lake (E110), and patients with galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
- Severe hepatic impairment
- Moderate or severe renal impairment (creatinine clearance < 50ml/min)
- If female, she is pregnant or breastfeeding
- Screening blood result with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed).
- Any condition (including drug/alcohol abuse) or laboratory results which, in the investigator's opinion, interfere with assessments or completion of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to investigate the benefits of switching away from efavirenz (which patients are taking in combination with Kivexa® or as part of the combination pill, Atripla®) in patients with central nervous system side effects (such as insomnia {difficulty with sleeping}, bad dreams etc). The investigators in this study will investigate the effect of switching to a single tablet regimen (Eviplera®) containing tenofovir, emtricitabine and rilpivirine. If patients are currently taking Atripla, rilpivirine will be the only new component of the combination.
Rilpivirine is a drug for HIV treatment, licensed for first-line treatment. In combination with Truvada®, it showed fewer side effects when compared to efavirenz in 2 other clinical studies, where patients were starting HIV treatment for the first time.
This study will also investigate the safety (in terms of other side effects and the routine blood tests which we ordinarily use to monitor your treatment) and monitor effectiveness, your viral load and CD4 counts, when you switch treatment to tenofovir/emtricitabine/rilpivirine.
- Conditions
- HIV
- Being tested
- tenofovir/emtricitabine/rilpivirine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tenofovir/emtricitabine/rilpivirineDrug
| Study group | Role | What they receive |
|---|---|---|
| tenofovir/emtricitabine/rilpivirine | Experimental | A one pill fixed dose combination of tenofovir 245mg, emtricitabine 200mg and rilpivirine 25mg once daily. Receives: Drug: tenofovir/emtricitabine/rilpivirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of toxicity after 12 weeks
To investigate whether switching individuals with intolerance to efavirenz-containing cART (as Atripla or Kivexa plus Efavarinz) to tenofovir/emtricitabine/rilpivirine is associated with resolution of toxicity after 12 weeks. CNS toxicity will be measured by a questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale.
Measured: 12 weeks
Secondary outcomes (1)
Resolution of toxicity after 24 weeks
To investigate whether switching to tenofovir/emtricitabine/rilpivirine is associated with resolution of toxicity after 24 weeks. CNS toxicity will be measured by a questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Stephens Aids Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701882
- Sponsor's protocol ID
- SSAT 047
- Status last verified
- Jul 2017
- First submitted
- 19 Sep 2012
- Last updated
- 26 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Feasibility of Switching, Individuals Receiving Atripla With Continuing Central Nervous System (CNS) Toxicity, to a Fixed Dose Combination of Tenofovir/Emtricitabine/Rilpivirine
- ClinicalTrials.gov ID
- NCT01701882
- Acronym / sponsor ID
- SSAT 047
- Conditions
- HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- St Stephens Aids TrustUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Oct 2012 (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 purpose of the study is to investigate the benefits of switching away from efavirenz (which patients are taking in combination with Kivexa® or as part of the combination pill, Atripla®) in patients with central nervous system side effects (such as insomnia {difficulty with sleeping}, bad dreams etc). The investigators in this study will investigate the effect of switching to a single tablet regimen (Eviplera®) containing tenofovir, emtricitabine and rilpivirine. If patients are currently taking Atripla, rilpivirine will be the only new component of the combination.
Rilpivirine is a drug for HIV treatment, licensed for first-line treatment. In combination with Truvada®, it showed fewer side effects when compared to efavirenz in 2 other clinical studies, where patients were starting HIV treatment for the first time.
This study will also investigate the safety (in terms of other side effects and the routine blood tests which we ordinarily use to monitor your treatment) and monitor effectiveness, your viral load and CD4 counts, when you switch treatment to tenofovir/emtricitabine/rilpivirine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tenofovir/emtricitabine/rilpivirine | Experimental | Drug: tenofovir/emtricitabine/rilpivirineA one pill fixed dose combination of tenofovir 245mg, emtricitabine 200mg and rilpivirine 25mg once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient volunteers who meet all of the following criteria are eligible for this trial:
Key exclusion criteria (14 listed)
- Patients meeting 1 or more of the following criteria cannot be selected:
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 |
|---|---|---|
| tenofovir/emtricitabine/rilpivirine | Drug | tenofovir/emtricitabine/rilpivirine |
Primary outcome
Resolution of toxicity after 12 weeks
Time frame: 12 weeks
To investigate whether switching individuals with intolerance to efavirenz-containing cART (as Atripla or Kivexa plus Efavarinz) to tenofovir/emtricitabine/rilpivirine is associated with resolution of toxicity after 12 weeks. CNS toxicity will be measured by a questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale.
1 secondary outcome
Resolution of toxicity after 24 weeks
Time frame: 24 weeks
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 26 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tenofovir/emtricitabine/rilpivirine in people with HIV, run by St Stephens Aids Trust at 1 site 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 12 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: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Resolution of toxicity after 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2017.