HIVPhase 4NCT02487706
Assessment of Dolutegravir Removed by Hemodialysis in HIV-infected Patients With End-stage Renal Disease
A Phase 4 study testing Dolutegravir in people with HIV, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.
Trial summary
Data on the capacity of hemodialysis to remove dolutegravir (DTG) from plasma in patients with end-stage renal disease (ESRD) on hemodialysis (HD) are lacking. If DTG was removed from plasma by HD, it would be possible to have subtherapeutic drug concentrations at the end of HD sessions. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV
- What is being tested?
- Dolutegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2015to Jul 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 1 years old or older.
- HIV documented infection (western blot)
- ESRD undergoing routine hemodialysis
- Stable antiretroviral treatment (no changes within the prior 2 weeks)
- Signature of informed consent
Who cannot join
- Inadequate adherence to antiretroviral treatment (<90% in the week prior to inclusion).
- Clinical evidence or suspicion that the patient will not be able to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Removal of Dolutegravir by Hemodialysis in HIV-infected Patients With End-stage Renal Disease
Data on the capacity of hemodialysis to remove dolutegravir (DTG) from plasma in patients with end-stage renal disease (ESRD) on hemodialysis (HD) are lacking. If DTG was removed from plasma by HD, it would be possible to have subtherapeutic drug concentrations at the end of HD sessions.
Read the detailed description
The prevalence of chronic renal disease and end-stage renal disease (ESRD) is increasing in the HIV-positive population. This means that an increasing number of HIV-infected patients will need renal replacement therapy.However, little is known about DTG removal from plasma by HD in patients with ESRD.
Objective: to evaluate the effect of HD on DTG clearance as well as on DTG plasma concentrations at steady state in HIV-infected patients with ESRD undergoing HD.
- Conditions
- HIV
- Being tested
- Dolutegravir
- Keywords
- Hemodialysis, HIV-infection
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DolutegravirDrug
Dolutegravir 50mg/day per 5 days
| Study group | Role | What they receive |
|---|---|---|
| Dolutegravir 50mg/day per 5 days | Experimental | Dolutegravir 50mg/day per 5 days Receives: Drug: Dolutegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodialysis extraction ratio of dolutegravir
Measured: Day 5
hemodialysis clearance of dolutegravir
Measured: Day 5
Secondary outcomes (1)
percentage of patients presenting adverse events related to dolutegravir
Measured: From Baseline to day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionJul 2015
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.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487706
- Sponsor's protocol ID
- DTG_HD
- Status last verified
- Sep 2015
- First submitted
- 29 Jun 2015
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Molto J, Graterol F, Miranda C, Khoo S, Bancu I, Amara A, Bonjoch A, Clotet B. Removal of Dolutegravir by Hemodialysis in HIV-Infected Patients with End-Stage Renal Disease. Antimicrob Agents Chemother. 2016 Mar 25;60(4):2564-6. doi: 10.1128/AAC.03131-15. Print 2016 Apr.
PubMed 26856824
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removal of Dolutegravir by Hemodialysis in HIV-infected Patients With End-stage Renal Disease
- ClinicalTrials.gov ID
- NCT02487706
- Acronym / sponsor ID
- DTG_HD
- Conditions
- HIV
- Keywords
- Hemodialysis, HIV-infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 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.
Data on the capacity of hemodialysis to remove dolutegravir (DTG) from plasma in patients with end-stage renal disease (ESRD) on hemodialysis (HD) are lacking. If DTG was removed from plasma by HD, it would be possible to have subtherapeutic drug concentrations at the end of HD sessions.
Detailed description
The prevalence of chronic renal disease and end-stage renal disease (ESRD) is increasing in the HIV-positive population. This means that an increasing number of HIV-infected patients will need renal replacement therapy.However, little is known about DTG removal from plasma by HD in patients with ESRD.
Objective: to evaluate the effect of HD on DTG clearance as well as on DTG plasma concentrations at steady state in HIV-infected patients with ESRD undergoing HD.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dolutegravir 50mg/day per 5 days | Experimental | Drug: DolutegravirDolutegravir 50mg/day per 5 days |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 1 years old or older.
- HIV documented infection (western blot)
- ESRD undergoing routine hemodialysis
- Stable antiretroviral treatment (no changes within the prior 2 weeks)
- Signature of informed consent
Key exclusion criteria (2 listed)
- Inadequate adherence to antiretroviral treatment (<90% in the week prior to inclusion).
- Clinical evidence or suspicion that the patient will not be able to comply with the study protocol.
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 |
|---|---|---|
| DolutegravirDolutegravir 50mg/day per 5 days | Drug | Dolutegravir 50mg/day per 5 days |
Primary outcome
hemodialysis extraction ratio of dolutegravir
Time frame: Day 5
hemodialysis clearance of dolutegravir
Time frame: Day 5
1 secondary outcome
percentage of patients presenting adverse events related to dolutegravir
Time frame: From Baseline to day 5
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 1 Oct 2015.
- Derived from this study: PubMed 26856824Molto J, Graterol F, Miranda C, Khoo S, Bancu I, Amara A, Bonjoch A, Clotet B. Removal of Dolutegravir by Hemodialysis in HIV-Infected Patients with End-Stage Renal Disease. Antimicrob Agents Chemother. 2016 Mar 25;60(4):2564-6. doi: 10.1128/AAC.03131-15. Print 2016 Apr.
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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 Dolutegravir in people with HIV, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.
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 5 inclusion and 2 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 1 Oct 2015. 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 Spain. 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?
hemodialysis extraction ratio of dolutegravir (time frame: Day 5). The study lists 2 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 NCT02487706, 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 1 Oct 2015.