HIVPhase 2/3NCT03033368

Rilpivirine in Virologically Suppressed Adolescents

A Phase 2/3 study testing Rilpivirine in people with HIV, run by Mahidol University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

To describe the immunologic and virologic outcomes (HIV RNA, CD4) following switching from EFV to RPV in virologically suppressed adolescents Read more about this study

Who is it for?: Ages 12 to 18 years
Conditions the study is for: HIV
What is being tested?: Rilpivirine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: No sites listed yet
Study dates: Jul 2015to Dec 2017
Phase: Phase 2/3
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 12 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

HIV-infected adolescents aged 12-18 years;
Body weight >25 kilograms;
Currently treated with stable EFV-based HAART (EFV plus two nucleoside or nucleotide reverse transcriptase inhibitors [N(t)RTI]) for >3 months prior to enrollment;
Plasma HIV RNA <50 copies/ml within the last 12 months;
ALT <200 IU/L within the last 12 months;
Caregivers give written informed consent and adolescents who know their HIV status (i.e., have been fully disclosed to) give assent

Who cannot join

Has evidence of NNRTI-associated resistance mutation(s) from previous genotypic resistance testing;
Currently has PI(s) in the HAART regimen;
Has currently active HIV-related infection(s), (The subject can be enrolled after the infection is under controlled);
Has significant medical problem(s) that would compromise study results (in the site principal investigator's opinion);
Pregnancy (postpartum women are allowed);
Concomitant treatment with drugs known to effect the PK of RPV (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin, omeprazole, esomeprazole, lansoprazole, erythromycin, clarithromycin, azithromycin, roxithromycin)

About this study

Official title: Treatment Switch From Efavirenz to Rilpivirine in Virologically-suppressed HIV-infected Thai Adolescents

To describe the immunologic and virologic outcomes (HIV RNA, CD4) following switching from EFV to RPV in virologically suppressed adolescents

Read the detailed description

Study Procedures:

At screening, the informed consent process will be provided to participant, or participant legally acceptable representatives before any study procedure. Only adolescents who know their HIV status will be asked to give assent.

Twenty adolescents followed at HIV-NAT and the Department of Pediatrics, Faculty of Medicine, Chulalongkorn University will be asked to participate in the PK sub study. Participant who are enrolled in the PK substudy will be asked to take RPV in the morning after breakfast and then commence the PK evaluations after this witnessed dose. After the PK study at week 4, Participant will be followed with the other 80 adolescents until the end of the study. Participant will be asked to provide a small hair sample for RPV concentrations at weeks 4, 12, 24, and 48 after switching. This is an option therefore participant can refuse to provide their hair samples at any visits. HIV RNA levels will be performed at baseline, week 12, 24 and 48 visits. If the HIV-RNA at any visits is between >50 copies/ml, the HIV-RNA test will be repeated within 4-8 weeks with adherence improvement counseling. At any visit, if HIV-RNA is ≥1000 copies/ml, genotypic resistance testing will be performed. Modification of treatment both for resistance and safety consideration will be subject to the site principal investigator's decision.

Conditions: HIV
Being tested: Rilpivirine
Keywords: immunological outcome, virologic outcomes, HIV-1 infected adolescents, EFV switch to RPV, Rilpivirine pharmacokinetic, neuropsychiatric adverse events

What participants receive

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

RilpivirineDrug
Also called Edurant
Rilpivirine 25 mg tablet

Study groups in NCT03033368
Study group	Role	What they receive
opened label	Experimental	Open-label, single-arm study, rilpivirine is the study drug Receives: Drug: Rilpivirine

What is being measured

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

Proportion of adolescents with HIV-RNA <50 copies/ml at 48 weeks after switching.
Measured: 48 weeks

Secondary outcomes (8)

Change in neuropsychiatric test scores
Using Trail Making Test and Coding subtest of WISC-III Wisconsin Card Sorting Test (WCST) Non-verbal part of Standard Progressive Matrices
Measured: Baseline and week 24
Change in quality of life (QOL) score
Using PedsQLTM 4.0
Measured: Baseline, week 4 and week 24
Change in lipid profiles after switching to RPV-containing regimens
Measure cholesterol (mg/dl), LDL (mg/dl), HDL (mg/dl), triglyceride (mg/dl)
Measured: Baseline, week 24, and week 48
Change in fasting blood sugar after switching to RPV-containing regime
Measue fasting blood sugar (mg/dl)
Measured: Baseline, week 24, and week 48
Intensive PK parameter (Area under the plasma concentration-time curve; AUC0-24) of RPV in 20 subjects at 4 weeks after switching to RPV-containing regimens.
Measure area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24): unit; ng.h/ml
Measured: week 4
Intensive PK parameter (maximum observed concentration of drug in plasma ;(Cmax) ) of RPV in 20 subjects at 4 weeks after switching to RPV-containing regimens.
Measue maximum observed concentration of drug in plasma (Cmax) : unit; ng/ml
Measured: week 4
Intensive PK parameter (Minimum concentration of drug in plasma; (Ctrough)) of RPV in 20 subjects at 4 weeks after switching to RPV-containing regimens.
Measure minimum concentration of drug in plasma (Ctrough) : unit; ng/ml
Measured: week 4
Description of resistance mutations in the adolescents with RPV treatment failure
At any visit, if HIV-RNA is ≥1000 copies/ml, genotypic resistance testing will be performed. Using HIV-1 Antiretroviral drug resistance ViriSeq HIV-1 genotyping
Measured: baseline, week 12, week 24 and week 48

Timeline

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

Jul 2015Dec 2017

First posted26 Jan 2017 (estimated)
Study startJul 2015
Primary completionJun 2017 (estimated)
Study completionDec 2017 (estimated)

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 HIVStudies of the same condition, open and under way.
More trials run by Mahidol UniversityThe sponsor's other registered studies.
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 2/3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03033368
Sponsor's protocol ID: RPV
Status last verified: Jan 2017
First submitted: 22 Oct 2016
Last updated: 26 Jan 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: Investigator plan to the clinical data

Publications

Jantarabenjakul W, Anugulruengkitt S, Kasipong N, Thammajaruk N, Sophonphan J, Bunupuradah T, Cressey TR, Colbers A, Burger DM, Phongsamart W, Puthanakit T, Pancharoen C; HIVNAT 220 study. Pharmacokinetics of rilpivirine and 24-week outcomes after switching from efavirenz in virologically suppressed HIV-1-infected adolescents. Antivir Ther. 2018;23(3):259-265. doi: 10.3851/IMP3198.
PubMed 28994660

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment Switch From Efavirenz to Rilpivirine in Virologically-suppressed HIV-infected Thai Adolescents
ClinicalTrials.gov ID: NCT03033368
Acronym / sponsor ID: RPV
Conditions: HIV
Keywords: immunological outcome, virologic outcomes, HIV-1 infected adolescents, EFV switch to RPV, Rilpivirine pharmacokinetic, neuropsychiatric adverse events
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (actual)
Lead sponsor: Mahidol UniversityUniversity, hospital or other
Collaborators: amfAR, The Foundation for AIDS Research
Study start: Jul 2015
Primary completion: Jun 2017 (estimated)
Study completion: Dec 2017 (estimated)
First posted: 26 Jan 2017 (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.

To describe the immunologic and virologic outcomes (HIV RNA, CD4) following switching from EFV to RPV in virologically suppressed adolescents

Detailed description

Study Procedures:

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
opened label	Experimental	Drug: RilpivirineOpen-label, single-arm study, rilpivirine is the study drug

Who may qualify

Ages: 12 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

HIV-infected adolescents aged 12-18 years;
Body weight >25 kilograms;
Currently treated with stable EFV-based HAART (EFV plus two nucleoside or nucleotide reverse transcriptase inhibitors [N(t)RTI]) for >3 months prior to enrollment;
Plasma HIV RNA <50 copies/ml within the last 12 months;
ALT <200 IU/L within the last 12 months;

Key exclusion criteria (6 listed)

Has evidence of NNRTI-associated resistance mutation(s) from previous genotypic resistance testing;
Currently has PI(s) in the HAART regimen;
Has currently active HIV-related infection(s), (The subject can be enrolled after the infection is under controlled);
Has significant medical problem(s) that would compromise study results (in the site principal investigator's opinion);
Pregnancy (postpartum women are allowed);

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
RilpivirineAlso: EdurantRilpivirine 25 mg tablet	Drug	opened label

Primary outcome

Proportion of adolescents with HIV-RNA <50 copies/ml at 48 weeks after switching.
Time frame: 48 weeks

8 secondary outcomes

Change in neuropsychiatric test scores
Time frame: Baseline and week 24
Change in quality of life (QOL) score
Time frame: Baseline, week 4 and week 24
Change in lipid profiles after switching to RPV-containing regimens
Time frame: Baseline, week 24, and week 48
Change in fasting blood sugar after switching to RPV-containing regime
Time frame: Baseline, week 24, and week 48
Intensive PK parameter (Area under the plasma concentration-time curve; AUC0-24) of RPV in 20 subjects at 4 weeks after switching to RPV-containing regimens.
Time frame: week 4
Intensive PK parameter (maximum observed concentration of drug in plasma ;(Cmax) ) of RPV in 20 subjects at 4 weeks after switching to RPV-containing regimens.
Time frame: week 4
Intensive PK parameter (Minimum concentration of drug in plasma; (Ctrough)) of RPV in 20 subjects at 4 weeks after switching to RPV-containing regimens.
Time frame: week 4
Description of resistance mutations in the adolescents with RPV treatment failure
Time frame: baseline, week 12, week 24 and week 48

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
Derived from this study: PubMed 28994660Jantarabenjakul W, Anugulruengkitt S, Kasipong N, Thammajaruk N, Sophonphan J, Bunupuradah T, Cressey TR, Colbers A, Burger DM, Phongsamart W, Puthanakit T, Pancharoen C; HIVNAT 220 study. Pharmacokinetics of rilpivirine and 24-week outcomes after switching from efavirenz in virologically suppressed HIV-1-infected adolescents. Antivir Ther. 2018;23(3):259-265. doi: 10.3851/IMP3198.
Individual participant dataSharing planned: Yes. Investigator plan to the clinical data

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Not yet recruiting
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Recruiting
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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.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Rilpivirine in people with HIV, run by Mahidol University.

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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

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

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?

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?

Proportion of adolescents with HIV-RNA <50 copies/ml at 48 weeks after switching. (time frame: 48 weeks). 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 NCT03033368, 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 26 Jan 2017.