HIV-1-infectionNCT05495204
External Comparison of Ibalizumab in Trials vs. Other Regimens in OPERA
An observational study of HIV-1-infection, run by Epividian at 1 site in United States.
Trial summary
Among heavily treatment experienced people living with HIV, the virologic effectiveness of ibalizumab + optimized background regimen from two clinical trials will be compared to non-ibalizumab-containing regimens in routine clinical care in the OPERA cohort. 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?
- Ibalizumab
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2022to 20 Feb 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All TMB-202 and TMB-301/311 trial participants randomized to 800 mg IBA every 2 weeks with or without a loading dose will be included in the main analyses. From the OPERA cohort, adult PWH with resistance from three ARV classes will be considered for inclusion. People with HIV in OPERA initiating a new non-IBA OBR between 01JAN2008 and 31DEC2020 will be included; person-time will be censored at the first of (a) initiation of a select potent ARV, (b) >45 days without ART, (c) 12 months after last clinical contact, (d) death, or (e) study end.
Who may be able to join
- Participant in TMB-202 or TMB-301/311
- Received 800 mg IBA every 2 weeks, with or without a loading dose
- HIV-1 infection
- 18 years or older
- Heavily treatment experienced (i.e., ever on a regimen containing either DTG BID or DRV BID)
- Documented resistance to ≥1 ARV from each of three ARV classes
Show all 17Show fewer
- Genotype information available for all the relevant gene regions (see Table 2)
- Viral load > 200 copies/mL at index regimen initiation
- Not pregnant at index
- No new AIDS defining event within 3 months before/on index (except cutaneous Kaposi's sarcoma or HIVAW)
- No new cancer diagnosis within 12 weeks before/on index
- No IBA prescribed prior to/with the index regimen
- Index regimen does not include cabotegravir, fostemsavir, investigational drugs
- Viral sensitivity/susceptibility to at least one ARV in the index regimen
- Baseline VL available (within 6 months before/at index)
- Baseline CD4 available (within 6 months before/at index)
- ≥1 VL measurement at any time after index
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Comparison of Effectiveness of Ibalizumab in Clinical Trials vs. Other HTE Regimens in OPERA
Among heavily treatment experienced people living with HIV, the virologic effectiveness of ibalizumab + optimized background regimen from two clinical trials will be compared to non-ibalizumab-containing regimens in routine clinical care in the OPERA cohort.
Read the detailed description
The US Department of Health and Human Services (DHHS) HIV treatment guideline suggest that ibalizumab may be considered in the context of multidrug resistance without fully active ART options. However, clinical trials assessing ibalizumab efficacy did not include an active comparison arm in which participants did not receive ibalizumab. The use of external controls can provide valuable information and context to interpret the results of clinical trials when randomization to a control arm cannot be performed.
The OPERA (Observational Pharmaco-Epidemiology Research \& Analysis) cohort, a large US electronic health record database, is well suited for this as the OPERA and trials populations arose from the same geographic location (i.e., US). An external comparison of ibalizumab + optimized background regimen from trials vs. non-ibalizumab containing regimens in routine clinical care in the OPERA cohort may confirm results from prior studies suggesting viral control benefits of ibalizumab.
- Conditions
- HIV-1-infection
- Being tested
- Ibalizumab
- Keywords
- Heavily treatment experienced, External comparison, Ibalizumab, Virologic effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbalizumabDrug
Also called Regimens not containing ibalizumab
Participation in clinical trials vs. routine care in OPERA
| Study group | Role | What they receive |
|---|---|---|
| IBA+OBR (trials) | Participants in TMB-202 or TMB-301/311 trials who received 800 mg ibalizumab every 2 weeks, with or without a loading dose Receives: Drug: Ibalizumab | |
| Non-IBA+OBR (OPERA) | Heavily treatment experienced adults living with HIV in care in OPERA, with documented resistance to ≥1 ARV from each of three ARV classes switching to a new regimen that does not include ibalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral suppression
Viral load <200 copies/mL
Measured: Week 24
Viral suppression
Viral load <200 copies/mL
Measured: Week 48
Viral suppression
Viral load <200 copies/mL
Measured: Week 60
Viral suppression
Viral load <200 copies/mL
Measured: Week 96
Viral undetectability
Viral load <50 copies/mL
Measured: Week 24
Viral undetectability
Viral load <50 copies/mL
Measured: Week 48
Viral undetectability
Viral load <50 copies/mL
Measured: Week 60
Viral undetectability
Viral load <50 copies/mL
Measured: Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start5 Aug 2022
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epividian
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Theratechnologies, FIECON
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495204
- Sponsor's protocol ID
- COL2022-001
- Status last verified
- Sep 2023
- First submitted
- 5 Aug 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Comparison of Effectiveness of Ibalizumab in Clinical Trials vs. Other HTE Regimens in OPERA
- ClinicalTrials.gov ID
- NCT05495204
- Acronym / sponsor ID
- COL2022-001
- Conditions
- HIV-1-infection
- Keywords
- Heavily treatment experienced, External comparison, Ibalizumab, Virologic effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- EpividianIndustry (pharma, biotech, devices)
- Collaborators
- Theratechnologies, FIECON
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 10 Aug 2022 (actual)
- 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.
Among heavily treatment experienced people living with HIV, the virologic effectiveness of ibalizumab + optimized background regimen from two clinical trials will be compared to non-ibalizumab-containing regimens in routine clinical care in the OPERA cohort.
Detailed description
The US Department of Health and Human Services (DHHS) HIV treatment guideline suggest that ibalizumab may be considered in the context of multidrug resistance without fully active ART options. However, clinical trials assessing ibalizumab efficacy did not include an active comparison arm in which participants did not receive ibalizumab. The use of external controls can provide valuable information and context to interpret the results of clinical trials when randomization to a control arm cannot be performed.
The OPERA (Observational Pharmaco-Epidemiology Research \& Analysis) cohort, a large US electronic health record database, is well suited for this as the OPERA and trials populations arose from the same geographic location (i.e., US). An external comparison of ibalizumab + optimized background regimen from trials vs. non-ibalizumab containing regimens in routine clinical care in the OPERA cohort may confirm results from prior studies suggesting viral control benefits of ibalizumab.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBA+OBR (trials) | – | Drug: IbalizumabParticipants in TMB-202 or TMB-301/311 trials who received 800 mg ibalizumab every 2 weeks, with or without a loading dose |
| Non-IBA+OBR (OPERA) | – | –Heavily treatment experienced adults living with HIV in care in OPERA, with documented resistance to ≥1 ARV from each of three ARV classes switching to a new regimen that does not include ibalizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All TMB-202 and TMB-301/311 trial participants randomized to 800 mg IBA every 2 weeks with or without a loading dose will be included in the main analyses. From the OPERA cohort, adult PWH with resistance from three ARV classes will be considered for inclusion. People with HIV in OPERA initiating a new non-IBA OBR between 01JAN2008 and 31DEC2020 will be included; person-time will be censored at the first of (a) initiation of a select potent ARV, (b) >45 days without ART, (c) 12 months after last clinical contact, (d) death, or (e) study end.
Key inclusion criteria (17 listed)
- Participant in TMB-202 or TMB-301/311
- Received 800 mg IBA every 2 weeks, with or without a loading dose
- HIV-1 infection
- 18 years or older
- Heavily treatment experienced (i.e., ever on a regimen containing either DTG BID or DRV BID)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| IbalizumabAlso: Regimens not containing ibalizumabParticipation in clinical trials vs. routine care in OPERA | Drug | IBA+OBR (trials) |
Primary outcome
Viral suppression
Time frame: Week 24
Viral load <200 copies/mL
Viral suppression
Time frame: Week 48
Viral load <200 copies/mL
Viral suppression
Time frame: Week 60
Viral load <200 copies/mL
Viral suppression
Time frame: Week 96
Viral load <200 copies/mL
Viral undetectability
Time frame: Week 24
Viral load <50 copies/mL
Viral undetectability
Time frame: Week 48
Viral load <50 copies/mL
Viral undetectability
Time frame: Week 60
Viral load <50 copies/mL
Viral undetectability
Time frame: Week 96
Viral load <50 copies/mL
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 7 Sep 2023.
- Individual participant dataSharing planned: No
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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?
An observational study of HIV-1-infection, run by Epividian at 1 site in United States.
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 17 inclusion and 0 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 7 Sep 2023. 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 States. 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.
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?
Viral suppression (time frame: Week 24). The study lists 8 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 7 Sep 2023.