HIVPhase 4NCT01736761
A Phase IV, Open-label Single-arm Study Investigating the Pharmacokinetics and Pharmacodynamics of the Antiretroviral Combination of Rilpivirine and Ritonavirboosted Darunavir in Therapy-naive HIV-1 Infected Patients.
A Phase 4 study testing Darunavir, Ritonavir and Rilpivirine in people with HIV, run by St Stephens Aids Trust at 1 site in United Kingdom.
Trial summary
For patients who are starting to take antiretroviral medication (to treat HIV) for the first time, there are now a variety of different medicines which may be taken together as a combination in order to form an effective treatment which suppresses the virus for prolonged periods of time. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV
- What is being tested?
- Darunavir, Ritonavir and Rilpivirine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2012to Mar 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has signed and dated informed consent document, confirming their knowledge of the pertinent aspects of the study and willingness to comply with all study requirements, prior to screening procedures.
- Male or female aged 18 to 65 years.
- HIV-1 infected with ≤ 14 days total exposure to antiretroviral therapy - prior antiretrovirals as post-exposure prophylaxis permissible if documented negative test at 3 months following exposure. If patient has previously taken up to and including 14 days antiretroviral therapy during HIV-1 infection, this must not be within 12 weeks of the screening visit and there must be an available genotypic resistance test after last intake which indicates full viral susceptibility to study medication.
- CD4 count >50 cells/mm3 at screening.
- HIV-1 RNA > 1000 copies/mL at screening.
- Women of childbearing potential (WoCBP); negative urine β-hCG pregnancy test at screen and baseline visit.
- WOCBP, male patients and their partners must use two forms of contraception, one of which is an effective barrier method, when participating in sexual activity which could result in conception throughout the study and for 28 days following the last dose of study medication.
Who cannot join
- Infected with HIV-2
- Any medical, psychiatric or substance misuse disorders felt by the investigator to impact on the subject's ability to participate in the study, including a positive urine test for drugs of abuse (cannabinoids are not exclusionary).
- Disallowed concomitant medication as per the summary of product characteristics for darunavir or rilpivirine (see section 5.2).
- Any genotypic resistance mutations on screening or prior tests to darunavir (V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V) or rilpivirine (K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, H221Y, F227C, M230I, and M230L).
- Screening ALT or AST elevation greater than 5 times the upper limit of normal.
- Any active opportunistic infection within 4 weeks prior to planned baseline visit.
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- Any active cardiovascular, pulmonary, hepatic, renal or metabolic disease, or therapy used to treat these diseases, which in the opinion of the investigator could affect the absorption, distribution, metabolism or efficacy of the study medication.
- Any known or suspected allergic reaction to the investigational products or excipients (including E110 allergy with regard to darunavir tablets).
- Hepatitis B or C co-infection (defined as positive hepatitis B surface antigen or positive hepatitis C antibody; patients with positive hepatitis C antibody with undetectable RNA will be eligible for inclusion).
- Estimated GFR (MDRD method) less than 50 ml/min
- Use of proton pump inhibitors, or H-2 antagonists more than once daily-Subject has one or more of the following risk factors for QTc prolongation:
- a confirmed prolongation of QT/QTc interval, e.g., repeated demonstration of QTcF (Fridericia correction) interval > 450 ms in the screening ECG. ii. pathological Q-waves (defined as Q-wave > 40 ms or depth > 0.4-0.5 mV). iii. evidence of ventricular pre-excitation. iv. electrocardiographic evidence of complete or incomplete left bundle branch block or complete or clinically significant incomplete right bundle branch block. v. evidence of second or third degree heart block. vi. intraventricular conduction delay with QRS duration > 120 ms. vii. bradycardia as defined by sinus rate < 50 bpm. viii. personal or family history of long QT syndrome. ix. personal history of cardiac disease (including congenital heart disease), symptomatic or asymptomatic arrhythmias, with the exception of sinus arrhythmia. x. syncopal episodes. xi. risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, hypomagnesemia).
Trial locations and contacts
1 site in 1 country.
About this study
For patients who are starting to take antiretroviral medication (to treat HIV) for the first time, there are now a variety of different medicines which may be taken together as a combination in order to form an effective treatment which suppresses the virus for prolonged periods of time. Currently, national guidelines recommend the use of two different drugs of one type (the nucleoside/ nucleotide reverse transcriptase inhibitors, NRTI often known as "nukes") with a third drug from one of two other types (either a nonnucleoside reverse transcriptase inhibitor, known as an NNRTI or "nonnuke", or a protease inhibitor, known as a PI) to form a treatment regime of three active drugs. In the UK and Europe, all PIs are given in combination with a small dose of a second PI, ritonavir, which has the effect of boosting the levels of the active PI in the bloodstream.
The investigators know from both research studies and patient experience in clinic that a combination of a ritonavirboosted PI with an NNRTI achieves similar results in suppressing the HIV virus, compared to the use of either a PI or NNRTI with 2 NRTI as described above. In this study, the investigators will observe the combination of two licensed antiretroviral medications, ritonavirboosted darunavir(DRV/r) and rilpivirine (RPV), in suppressing virus when given to patients who are commencing treatment for HIV infection for the first time. Both of these drugs are licensed for treatment of patients with HIV in the UK and Europe, and are currently in standard clinical use.
The study will monitor this treatment over the first 48 weeks. The investigators will also examine the levels of both drugs in the bloodstream during the first 4 weeks of starting this regimen, to confirm that they remain at levels which the investigators know to be effective against the virus.
- Conditions
- HIV
- Being tested
- Darunavir, Ritonavir and Rilpivirine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darunavir, Ritonavir and RilpivirineDrug
| Study group | Role | What they receive |
|---|---|---|
| Darunavir, Ritonavir, Rilpivirine | Experimental | Darunavir 800 mg once daily, Ritonavir 100 mg once daily and Rilpivirine 25 mg once daily Receives: Drug: Darunavir, Ritonavir and Rilpivirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic suppression after 48 weeks of therapy with the study regime
To describe the rate of virologic suppression after 48 weeks of therapy with the study regime. This will be measured by the proportion of patients with HIV-1 RNA ≤ 40 copies/mL at week 48
Measured: 48 weeks
Secondary outcomes (1)
To explore the virologic response to this combination rilpivirine and ritonavir-boosted darunavir at weeks 4, 8, 12 and 24 of therapy.
The proportion of enrolled patients with a reduction from baseline in HIV-1 RNA >1 log10 copies /mL at weeks 4, 8, 12 and proportion with HIV-1 RNA ≤400 copies/mL at week 24.
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 posted29 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2015
- Study completionMar 2015
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT01736761
- Sponsor's protocol ID
- SSAT 049
- Status last verified
- Jun 2017
- First submitted
- 26 Nov 2012
- Last updated
- 16 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open-label Single-arm Study Investigating the Pharmacokinetics and Pharmacodynamics of the Antiretroviral Combination of Rilpivirine and Ritonavirboosted Darunavir in Therapy-naive HIV-1 Infected Patients.
- ClinicalTrials.gov ID
- NCT01736761
- Acronym / sponsor ID
- SSAT 049
- Conditions
- HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- St Stephens Aids TrustUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Nov 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.
For patients who are starting to take antiretroviral medication (to treat HIV) for the first time, there are now a variety of different medicines which may be taken together as a combination in order to form an effective treatment which suppresses the virus for prolonged periods of time. Currently, national guidelines recommend the use of two different drugs of one type (the nucleoside/ nucleotide reverse transcriptase inhibitors, NRTI often known as "nukes") with a third drug from one of two other types (either a nonnucleoside reverse transcriptase inhibitor, known as an NNRTI or "nonnuke", or a protease inhibitor, known as a PI) to form a treatment regime of three active drugs. In the UK and Europe, all PIs are given in combination with a small dose of a second PI, ritonavir, which has the effect of boosting the levels of the active PI in the bloodstream.
The investigators know from both research studies and patient experience in clinic that a combination of a ritonavirboosted PI with an NNRTI achieves similar results in suppressing the HIV virus, compared to the use of either a PI or NNRTI with 2 NRTI as described above. In this study, the investigators will observe the combination of two licensed antiretroviral medications, ritonavirboosted darunavir(DRV/r) and rilpivirine (RPV), in suppressing virus when given to patients who are commencing treatment for HIV infection for the first time. Both of these drugs are licensed for treatment of patients with HIV in the UK and Europe, and are currently in standard clinical use.
The study will monitor this treatment over the first 48 weeks. The investigators will also examine the levels of both drugs in the bloodstream during the first 4 weeks of starting this regimen, to confirm that they remain at levels which the investigators know to be effective against the virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Darunavir, Ritonavir, Rilpivirine | Experimental | Drug: Darunavir, Ritonavir and RilpivirineDarunavir 800 mg once daily, Ritonavir 100 mg once daily and Rilpivirine 25 mg once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient has signed and dated informed consent document, confirming their knowledge of the pertinent aspects of the study and willingness to comply with all study requirements, prior to screening procedures.
- Male or female aged 18 to 65 years.
- HIV-1 infected with ≤ 14 days total exposure to antiretroviral therapy - prior antiretrovirals as post-exposure prophylaxis permissible if documented negative test at 3 months following exposure. If patient has previously taken up to and including 14 days antiretroviral therapy during HIV-1 infection, this must not be within 12 weeks of the screening visit and there must be an available genotypic resistance test after last intake which indicates full viral susceptibility to study medication.
- CD4 count >50 cells/mm3 at screening.
- HIV-1 RNA > 1000 copies/mL at screening.
Key exclusion criteria (12 listed)
- Infected with HIV-2
- Any medical, psychiatric or substance misuse disorders felt by the investigator to impact on the subject's ability to participate in the study, including a positive urine test for drugs of abuse (cannabinoids are not exclusionary).
- Disallowed concomitant medication as per the summary of product characteristics for darunavir or rilpivirine (see section 5.2).
- Any genotypic resistance mutations on screening or prior tests to darunavir (V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V) or rilpivirine (K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, H221Y, F227C, M230I, and M230L).
- Screening ALT or AST elevation 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 |
|---|---|---|
| Darunavir, Ritonavir and Rilpivirine | Drug | Darunavir, Ritonavir, Rilpivirine |
Primary outcome
Virologic suppression after 48 weeks of therapy with the study regime
Time frame: 48 weeks
To describe the rate of virologic suppression after 48 weeks of therapy with the study regime. This will be measured by the proportion of patients with HIV-1 RNA ≤ 40 copies/mL at week 48
1 secondary outcome
To explore the virologic response to this combination rilpivirine and ritonavir-boosted darunavir at weeks 4, 8, 12 and 24 of therapy.
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 16 Jun 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 4 study testing Darunavir, Ritonavir and 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 7 inclusion and 12 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 16 Jun 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 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?
Virologic suppression after 48 weeks of therapy with the study regime (time frame: 48 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 16 Jun 2017.