HIVPhase 4NCT02509195
SSAT064: Pharmacokinetics of Abacavir/Lamivudine/Dolutegravir in HIV Patients of 60 Years and Over
A Phase 4 study testing Triumeq in people with HIV, run by St Stephens Aids Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to identify the effects that ageing may have on the drug levels, the safety and the efficacy of Dolutegravir. These effects will be measured in people who are aged 60 or over and taking antiretroviral therapy for HIV infection. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Triumeq
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Aug 2015to 24 Jul 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infected males or females
- Has voluntarily signed informed consent after having enough time to consider the study information.
- Is willing to comply with the protocol requirements
- Documentation that the subject is negative for the HLA-B*5701 allele, either on historical sample or if none available, at screening.
- Aged 60 years and over (approximately 70% of the study participants will be ≥65 year of age), willing to switch therapy as per study protocol with no previous use of dolutegravir
- Plasma HIV RNA < 50 copies/mL at screening (single re-test allowed) and on at least one other occasion over the last 6-8 months
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- Has a CD4 cell count at screening >50 cells/mm3
- Currently receiving a stable antiretroviral regimen with no antiretroviral drug switches for at least 3 months prior to planned study baseline.
- No previous clinically-significant resistance documented on HIV-1 genotypic resistance to NRTIs and INIs
- Subjects in good health upon medical history, physical exam, and laboratory testing and with a clinically managed cardiovascular disease in the opinion of the Investigator
- Body mass over 40 kg and body mass index (BMI) above or equal to 18 and below 35
- Male subjects who are heterosexually active must be willing to use appropriate and consistent dual method contraception during heterosexual intercourse with women of child bearing potential, from screening through to one month post completion of the study. The following combined contraceptive methods are acceptable (please see appendix 3):
- Double barrier method:
- Male Condom combined with a Female Diaphragm with or without a vaginal spermicide* (foam, gel, film, cream, or suppository)
- Male Condom combined with a Cervical cap** (with spermicide)
- Male Condom + one of the following:
- Combined Oral Contraceptive Pill
- Combined Contraceptive Patch
- Combined Vaginal Ring
- The Progesterone Only Pill
- Intra-uterine Device (Copper IUD or the IUS)
- Injectable progestogen (Depo provera®)
- The progestogen-only Subdermal Implant
- Footnotes:
- *Cervical caps in women who have given birth is less effective than other methods of contraception.
- **Spermicide should be used with caution as this can potentially increase the rate of HIV-1 transmission.
- ***It is advised not to use a male and female condom together due to risk of breakage or damage caused by latex friction.
- If a female partner has had a total hysterectomy (surgical removal of the womb) or bilateral tubal ligation/clip (surgical sterilization), then she cannot get pregnant and the above section does not apply. If the male subject has had a vasectomy at least 1 month prior to starting the study, he does not need to use any other birth control.
Who cannot join
- History or presence of allergy to the study drugs or their components
- Infected with HIV-2
- Using any concomitant therapy disallowed as per SPC for the study drugs. The SPC of a drug is updated regularly. The most recent version can be found on http://www.medicines.org.uk/emc/
- Known acute viral hepatitis including, but not limited to, A, B, or C
- Known chronic hepatitis B and/or C
- Tests newly positive for active Hepatitis B (HBsAg positive), or active Hepatitis C (PCR positive) at screening visit
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- Any investigational drug within 30 days prior to the trial drug administration
- Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), OR ALT ≥3xULN and bilirubin ≥1.5xULN (with >35% direct bilirubin)
- Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification
- Moderate or severe renal impairment (creatinine clearance < 50ml/min)
- 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 the assessments or completion of the trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Stephen's Centre, Chelsea & Westminster Hospital
London, SW10 9NH
About this study
Official title: An Open Label Study to Investigate the Safety and Efficacy of Abacavir/Lamivudine/Dolutegravir and the Pharmacokinetic Profile of Dolutegravir in HIV-infected Patients of 60 Years of Age and Older
The purpose of this study is to identify the effects that ageing may have on the drug levels, the safety and the efficacy of Dolutegravir.
These effects will be measured in people who are aged 60 or over and taking antiretroviral therapy for HIV infection.
Read more
Dolutegravir is a newly licenced anti HIV medication, which belongs to a class of drugs called Integrase Inhibitors. It is taken with two other wellknown agents, Abacavir and Lamivudine, as part of a one tablet once a day regimen, called Triumeq. There is little data available on Dolutegravir in the context of older age. The HIV population is ageing and the investigators know that older age can significantly change the effects and side effects of medications, including that of antiretrovirals.
The investigators aim to investigate the treatment outcomes in older people taking Dolutegravir including the tolerability, efficacy and safety of the drug.
The study will also assess the quality of life (wellbeing of individuals) and cognition (mental abilities) of people aged 60 or over, taking Dolutegravir. The results from this study may inform treatment choices and monitoring in this population in the future.
The duration of involvement in the study will be 6 months with an additional screening visit and a checkup visit 10 days after end of study visit.
Read the detailed description
Protocol Number: SSAT 064
EudraCT Number: 2014-004970-40
Name of Investigational Product:Triumeq®
Name of active ingredients:Abacavir/lamivudine/dolutegravir
Study title: An open label study to investigate the safety and efficacy of abacavir/lamivudine/dolutegravir and the pharmacokinetic profile of dolutegravir in HIV-infected patients of 60 years of age and older
Objectives:
Primary:
- To assess the steady state pharmacokinetics of dolutegravir 50 mg once daily in HIV-infected subjects of 60 years or greater
Secondary:
- To assess the safety, tolerability, patient quality of life and sleep quality and maintenance of HIV viral load control of abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater
- To measure the metabolic profile in patients over the age of 60 with HIV infection who switch antiretroviral regime (metabonomics)
- To investigate cerebral function via cognitive testing before and after a switch in antiretroviral therapy to dolutegravir containing regimens
- To investigate the relationship between genetic polymorphisms and exposure to dolutegravir
Study design:Multi -centre, 180 days (excluding screening and follow up), open label, prospective, one phase pharmacokinetic/pharmacodynamic study
Indication:HIV-1 infection
Methodology:HIV-1 infected subjects will be recruited from four different HIV clinics. Eligible subjects currently receiving stable antiretroviral therapy with an undetectable plasma HIV RNA and with no evidence of previous HIV resistance mutations on genotypic resistance testing, will switch their treatment to abacavir/lamivudine/dolutegravir and undergo a 24 hour pharmacokinetic assessment at day 28 (+/- 1). Monitoring of adverse events (not at screening), viral load, quality of life and sleep quality, will occur at screening and on days 1, 28, 90, and 180. Cognitive function will be tested at screening, baseline and day 180. A sleep diary will be completed between day 1 and day 28.
Planned sample size:A sample size of 40 patients would provide at least 80% power to detect changes in dolutegravir exposure in older people.
Up to 45 subjects may be screened to have 40 patients completing the study.
Summary of eligibility criteria:HIV-1 infected subjects currently receiving stable antiretroviral therapy with undetectable plasma HIV RNA and no evidence of previous HIV- resistance mutations on genotypic resistance testing, 60 years old or older (approximately 30% between 60 and 64 and approximately 70% above the age of 65)
Number of study centres: 4 centres:
Chelsea and Westminster Hospital, London Royal Sussex County Hospital, Brighton St. Mary's Hospital Clinical Trials Centre, London Mortimer Market Centre, UCL, London
Duration of treatment: 180 (+/- 7) days
Dose and route of administration: All study drugs will be administered orally to subjects with the following schedule: Abacavir/lamivudine/dolutegravir one pill once daily
Criteria for evaluation:
Pharmacokinetic parameters of dolutegravir will be evaluated on blood drawn on day 28 (+/- 1) at 0 (pre-dose), 1, 2, 3, 4, 8, 12 and 24 hours post dose.
Monitoring of adverse events (not at screening), viral load, quality of life and sleep quality will occur at screening and days 1, 28, 90, and 180. Cognitive function will be tested at screening, baseline and day 180.
Primary Endpoint:
- Steady state plasma concentrations of dolutegravir when administered to HIV-infected individuals over the age of 60/65 years.
Secondary Endpoints:
- Safety, tolerability, maintenance of HIV viral load control, quality of life and sleep quality with abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater
- Measurement of the metabolic profile in patients over the age of 60 with HIV infection who switch antiretroviral regime (metabonomics)
- Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to dolutegravir containing regimens
- Relationship between genetic polymorphisms and exposure to dolutegravir.
- Conditions
- HIV
- Being tested
- Triumeq
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriumeqDrug
Also called abacavir/lamivudine/dolutegravir
Subjects will take the last dose of their current antiretroviral combination at its usual time on the day before the baseline visit (day 1) and will switch on day 1 to Abacavir/lamivudine/dolutegravir 600mg/300mg/50mg (Triumeq) fixed dose combination once daily between day 1 and day 180.
| Study group | Role | What they receive |
|---|---|---|
| Switch to Triumeq | Experimental | HIV-1 infected subjects currently receiving stable antiretroviral therapy switch their treatment to abacavir/lamivudine/dolutegravir (Triumeq). Receives: Drug: Triumeq |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady state plasma concentrations of dolutegravir when administered to HIV-infected individuals over the age of 60/65 years.
Measured: Day 28
Secondary outcomes (10)
Safety on abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater - measured by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events.
Measured: Up to day 190
Tolerability on abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater- measured by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events.
Measured: Up to day 190
Maintenance of HIV viral load control on abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater.
Measured: Up to day 190
Quality of life on abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater.- Measured by questionnaire
Measured: Up to day 190
Sleep Quality on abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater - Measured by questionnaire
Measured: Up to day 190
Measurement of the metabolic profile in patients over the age of 60 with HIV infection who switch antiretroviral regime (metabonomics)
Measured: Up to day 180
Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to a dolutegravir containing regimen
Measured: Up to day 180
Relationship between genetic polymorphisms and exposure to dolutegravir as measured by Peak plasma concentration (Cmax)
The results of genetic polymorphisms testing indicating the presence or absence of certain polymorphisms coding for enzymes and transporters responsible for the metabolism of dolutegravir will be correlated with the PK parameter Peak plasma concentration (Cmax). This, for instance, can tell us if the presence of certain alleles makes an individual more likely to metabolise or clear dolutegravir faster or slower.
Measured: Day 1
Relationship between genetic polymorphisms and exposure to dolutegravir as measured by trough concentration (Ctrough)
The results of genetic polymorphisms testing indicating the presence or absence of certain polymorphisms coding for enzymes and transporters responsible for the metabolism of dolutegravir will be correlated with the PK parameter trough concentration (Ctrough). This, for instance, can tell us if the presence of certain alleles makes an individual more likely to metabolise or clear dolutegravir faster or slower.
Measured: Day 1
Relationship between genetic polymorphisms and exposure to dolutegravir as measured by Area under the plasma concentration versus time curve (AUC)
The results of genetic polymorphisms testing indicating the presence or absence of certain polymorphisms coding for enzymes and transporters responsible for the metabolism of dolutegravir will be correlated with the PK parameter Area under the plasma concentration versus time curve (AUC). This, for instance, can tell us if the presence of certain alleles makes an individual more likely to metabolise or clear dolutegravir faster or slower.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study start4 Aug 2015
- Primary completion13 Feb 2017
- Study completion24 Jul 2017
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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Stephens Aids Trust
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Marta Boffito, Principal investigator, St Stephen's AIDS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509195
- Sponsor's protocol ID
- SSAT064
- Other IDs
- 2014-004970-40, 2014
- Status last verified
- Feb 2018
- First submitted
- 8 Jul 2015
- Last updated
- 28 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Investigate the Safety and Efficacy of Abacavir/Lamivudine/Dolutegravir and the Pharmacokinetic Profile of Dolutegravir in HIV-infected Patients of 60 Years of Age and Older
- ClinicalTrials.gov ID
- NCT02509195
- Acronym / sponsor ID
- SSAT064
- Conditions
- HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St Stephens Aids TrustUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 4 Aug 2015 (actual)
- Primary completion
- 13 Feb 2017 (actual)
- Study completion
- 24 Jul 2017 (actual)
- First posted
- 27 Jul 2015 (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 this study is to identify the effects that ageing may have on the drug levels, the safety and the efficacy of Dolutegravir.
These effects will be measured in people who are aged 60 or over and taking antiretroviral therapy for HIV infection.
Dolutegravir is a newly licenced anti HIV medication, which belongs to a class of drugs called Integrase Inhibitors. It is taken with two other wellknown agents, Abacavir and Lamivudine, as part of a one tablet once a day regimen, called Triumeq. There is little data available on Dolutegravir in the context of older age. The HIV population is ageing and the investigators know that older age can significantly change the effects and side effects of medications, including that of antiretrovirals.
The investigators aim to investigate the treatment outcomes in older people taking Dolutegravir including the tolerability, efficacy and safety of the drug.
The study will also assess the quality of life (wellbeing of individuals) and cognition (mental abilities) of people aged 60 or over, taking Dolutegravir. The results from this study may inform treatment choices and monitoring in this population in the future.
The duration of involvement in the study will be 6 months with an additional screening visit and a checkup visit 10 days after end of study visit.
Detailed description
Protocol Number: SSAT 064
EudraCT Number: 2014-004970-40
Name of Investigational Product:Triumeq®
Name of active ingredients:Abacavir/lamivudine/dolutegravir
Study title: An open label study to investigate the safety and efficacy of abacavir/lamivudine/dolutegravir and the pharmacokinetic profile of dolutegravir in HIV-infected patients of 60 years of age and older
Objectives:
Primary:
- To assess the steady state pharmacokinetics of dolutegravir 50 mg once daily in HIV-infected subjects of 60 years or greater
Secondary:
- To assess the safety, tolerability, patient quality of life and sleep quality and maintenance of HIV viral load control of abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater
- To measure the metabolic profile in patients over the age of 60 with HIV infection who switch antiretroviral regime (metabonomics)
- To investigate cerebral function via cognitive testing before and after a switch in antiretroviral therapy to dolutegravir containing regimens
- To investigate the relationship between genetic polymorphisms and exposure to dolutegravir
Study design:Multi -centre, 180 days (excluding screening and follow up), open label, prospective, one phase pharmacokinetic/pharmacodynamic study
Indication:HIV-1 infection
Methodology:HIV-1 infected subjects will be recruited from four different HIV clinics. Eligible subjects currently receiving stable antiretroviral therapy with an undetectable plasma HIV RNA and with no evidence of previous HIV resistance mutations on genotypic resistance testing, will switch their treatment to abacavir/lamivudine/dolutegravir and undergo a 24 hour pharmacokinetic assessment at day 28 (+/- 1). Monitoring of adverse events (not at screening), viral load, quality of life and sleep quality, will occur at screening and on days 1, 28, 90, and 180. Cognitive function will be tested at screening, baseline and day 180. A sleep diary will be completed between day 1 and day 28.
Planned sample size:A sample size of 40 patients would provide at least 80% power to detect changes in dolutegravir exposure in older people.
Up to 45 subjects may be screened to have 40 patients completing the study.
Summary of eligibility criteria:HIV-1 infected subjects currently receiving stable antiretroviral therapy with undetectable plasma HIV RNA and no evidence of previous HIV- resistance mutations on genotypic resistance testing, 60 years old or older (approximately 30% between 60 and 64 and approximately 70% above the age of 65)
Number of study centres: 4 centres:
Chelsea and Westminster Hospital, London Royal Sussex County Hospital, Brighton St. Mary's Hospital Clinical Trials Centre, London Mortimer Market Centre, UCL, London
Duration of treatment: 180 (+/- 7) days
Dose and route of administration: All study drugs will be administered orally to subjects with the following schedule: Abacavir/lamivudine/dolutegravir one pill once daily
Criteria for evaluation:
Pharmacokinetic parameters of dolutegravir will be evaluated on blood drawn on day 28 (+/- 1) at 0 (pre-dose), 1, 2, 3, 4, 8, 12 and 24 hours post dose.
Monitoring of adverse events (not at screening), viral load, quality of life and sleep quality will occur at screening and days 1, 28, 90, and 180. Cognitive function will be tested at screening, baseline and day 180.
Primary Endpoint:
- Steady state plasma concentrations of dolutegravir when administered to HIV-infected individuals over the age of 60/65 years.
Secondary Endpoints:
- Safety, tolerability, maintenance of HIV viral load control, quality of life and sleep quality with abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater
- Measurement of the metabolic profile in patients over the age of 60 with HIV infection who switch antiretroviral regime (metabonomics)
- Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to dolutegravir containing regimens
- Relationship between genetic polymorphisms and exposure to dolutegravir.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Switch to Triumeq | Experimental | Drug: TriumeqHIV-1 infected subjects currently receiving stable antiretroviral therapy switch their treatment to abacavir/lamivudine/dolutegravir (Triumeq). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- HIV-1 infected males or females
- Has voluntarily signed informed consent after having enough time to consider the study information.
- Is willing to comply with the protocol requirements
- Documentation that the subject is negative for the HLA-B*5701 allele, either on historical sample or if none available, at screening.
- Aged 60 years and over (approximately 70% of the study participants will be ≥65 year of age), willing to switch therapy as per study protocol with no previous use of dolutegravir
Key exclusion criteria (12 listed)
- History or presence of allergy to the study drugs or their components
- Infected with HIV-2
- Using any concomitant therapy disallowed as per SPC for the study drugs. The SPC of a drug is updated regularly. The most recent version can be found on http://www.medicines.org.uk/emc/
- Known acute viral hepatitis including, but not limited to, A, B, or C
- Known chronic hepatitis B and/or C
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 |
|---|---|---|
| TriumeqAlso: abacavir/lamivudine/dolutegravirSubjects will take the last dose of their current antiretroviral combination at its usual time on the day before the baseline visit (day 1) and will switch on day 1 to Abacavir/lamivudine/dolutegravir 600mg/300mg/50mg (Triumeq) fixed dose combination once daily between day 1 and day 180. | Drug | Switch to Triumeq |
Primary outcome
Steady state plasma concentrations of dolutegravir when administered to HIV-infected individuals over the age of 60/65 years.
Time frame: Day 28
10 secondary outcomes
Safety on abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater - measured by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events.
Time frame: Up to day 190
Tolerability on abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater- measured by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events.
Time frame: Up to day 190
Maintenance of HIV viral load control on abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater.
Time frame: Up to day 190
Quality of life on abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater.- Measured by questionnaire
Time frame: Up to day 190
Sleep Quality on abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater - Measured by questionnaire
Time frame: Up to day 190
Measurement of the metabolic profile in patients over the age of 60 with HIV infection who switch antiretroviral regime (metabonomics)
Time frame: Up to day 180
Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to a dolutegravir containing regimen
Time frame: Up to day 180
Relationship between genetic polymorphisms and exposure to dolutegravir as measured by Peak plasma concentration (Cmax)
Time frame: Day 1
Relationship between genetic polymorphisms and exposure to dolutegravir as measured by trough concentration (Ctrough)
Time frame: Day 1
Relationship between genetic polymorphisms and exposure to dolutegravir as measured by Area under the plasma concentration versus time curve (AUC)
Time frame: Day 1
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 28 Feb 2018.
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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.
Marta Boffito principal investigator
St Stephen's AIDS Trust
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 Triumeq 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 28 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 28 Feb 2018. 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?
Steady state plasma concentrations of dolutegravir when administered to HIV-infected individuals over the age of 60/65 years. (time frame: Day 28). 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 28 Feb 2018.