HIV-1-infectionNCT03198884
A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir
An observational study of HIV-1-infection, run by Southern Illinois Healthcare Foundation.
Trial summary
A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Darunavir 800 MG, Norvir 100 MG, Dolutegravir 50 MG
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 May 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Adult HIV positive patients
Who may be able to join
- ≥18 years old
- Received a regimen of darunavir 800 mg/ritonavir 100 mg in combination with dolutegravir 50 mg QD for ≥24 weeks as documented in EMR
- Laboratory reports (CD4, viral load, SrCr) available at time points +/- 4 6 weeks from 12, 24, 36, 48 weeks from start of regimen
- Resistance data (if applicable)
Who cannot join
- Received a regimen of darunavir/ritonavir in combination with dolutegravir for <24 weeks duration
- Patients receiving darunavir/ritonavir + DTG+NRTI's
- Missing laboratory data in ≥2 study time points
- Patients missing more than five doses over two weeks prior study visit
About this study
A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir
- Conditions
- HIV-1-infection
- Being tested
- Darunavir 800 MG, Norvir 100 MG, Dolutegravir 50 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darunavir 800 MG, Norvir 100 MG, Dolutegravir 50 MGDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With RNA <50 Copies/mL at 48 Weeks
Our first primary endpoint evaluated the percent of study subjects with an RNA <50 copies/mL at 48 weeks after initiation of the once daily two-drug regimen.
Measured: 48 weeks
The Change in Serum Creatinine From Baseline to 48 Weeks.
A second primary endpoint was evaluating the change in serum creatinine from baseline to 48 weeks for all subjects.
Measured: 48 weeks
Secondary outcomes (5)
Change in Mean CD4+ Cell Count From Baseline.
A secondary endpoint included changes from baseline in CD4+ cell counts.
Measured: 48 weeks
Incidence of Adverse Events.
10 study subjects reported an adverse event.
Measured: 48 weeks
Number of Grade 1 Adverse Events Reported
10 study subjects reported adverse events. All adverse events reported (insomnia, diarrhea, headache) were of Grade 1 severity.
There were no adverse events that led to discontinuation of the study regimen.
Measured: 48 weeks
Number of Participants With RNA <50 Copies/mL at 24, 36, and 48 Weeks
This secondary outcome measure analyzed the percentage of subjects with < 50 copies/mL RNA at time points 24, 36 and 48 weeks.
The percent of subjects with an RNA < 50 copies/mL at each time point was analyzed using McNemar's test following the guidelines of the Snapshot algorithm. Missing RNA data was considered a treatment failure.
Measured: 48 weeks
Analysis of Creatinine Clearance at Time Points 24, 36 and 48 Weeks.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start1 Jan 2017
- Primary completion18 Apr 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV-1-infectionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois Healthcare Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Principal investigator, John Verna, Southern Illinois Healthcare Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198884
- Sponsor's protocol ID
- 16-1108-100C
- Status last verified
- Aug 2020
- First submitted
- 5 Jun 2017
- Last updated
- 1 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir
- ClinicalTrials.gov ID
- NCT03198884
- Acronym / sponsor ID
- 16-1108-100C
- Conditions
- HIV-1-infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Southern Illinois Healthcare FoundationUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult HIV positive patients
Key inclusion criteria (4 listed)
- ≥18 years old
- Received a regimen of darunavir 800 mg/ritonavir 100 mg in combination with dolutegravir 50 mg QD for ≥24 weeks as documented in EMR
- Laboratory reports (CD4, viral load, SrCr) available at time points +/- 4 6 weeks from 12, 24, 36, 48 weeks from start of regimen
- Resistance data (if applicable)
Key exclusion criteria (4 listed)
- Received a regimen of darunavir/ritonavir in combination with dolutegravir for <24 weeks duration
- Patients receiving darunavir/ritonavir + DTG+NRTI's
- Missing laboratory data in ≥2 study time points
- Patients missing more than five doses over two weeks prior study visit
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 800 MG, Norvir 100 MG, Dolutegravir 50 MG | Drug | – |
Primary outcome
Number of Participants With RNA <50 Copies/mL at 48 Weeks
Time frame: 48 weeks
Our first primary endpoint evaluated the percent of study subjects with an RNA <50 copies/mL at 48 weeks after initiation of the once daily two-drug regimen.
The Change in Serum Creatinine From Baseline to 48 Weeks.
Time frame: 48 weeks
A second primary endpoint was evaluating the change in serum creatinine from baseline to 48 weeks for all subjects.
5 secondary outcomes
Change in Mean CD4+ Cell Count From Baseline.
Time frame: 48 weeks
Incidence of Adverse Events.
Time frame: 48 weeks
Number of Grade 1 Adverse Events Reported
Time frame: 48 weeks
Number of Participants With RNA <50 Copies/mL at 24, 36, and 48 Weeks
Time frame: 48 weeks
Analysis of Creatinine Clearance at Time Points 24, 36 and 48 Weeks.
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plan to share.
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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?
An observational study of HIV-1-infection, run by Southern Illinois Healthcare Foundation.
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 4 inclusion and 4 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 Sep 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With RNA <50 Copies/mL at 48 Weeks (time frame: 48 weeks). 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?
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 Sep 2020; AzTrials last refreshed its copy on 1 Nov 2026.