Human Immunodeficiency VirusPhase 1NCT05244473
A Safety Study of Brentuximab Vedotin in Participants With HIV
A Phase 1 study testing brentuximab vedotin and ART in people with Human Immunodeficiency Virus, run by Seagen Inc. at 2 sites in United States.
Trial summary
This study will test brentuximab vedotin to see if it is safe for people with human immunodeficiency virus (HIV) who have low CD4+ and have received antiretroviral therapy (ART) treatment. It will also see if brentuximab vedotin raises CD4+ counts. It will study the side effects of this drug as well. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- brentuximab vedotin and ART
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Dec 2022to 31 May 2024
- Phase
- Phase 1
- 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
Who may be able to join
- HIV-1 seropositive with documentation of infection
- Immunological nonresponder, defined as:
- Has been on ART with an HIV viral load <50 copies/mL for at least 24 months
- Has a CD4+ T-cell lymphocyte count between 51 to 200 cells/µL
- Life expectancy of >9 months.
- Participant is negative for hepatitis B, or if infected with hepatitis B, receiving anti-hepatitis B therapy
- Participants with a history of hepatitis C virus (HCV) are eligible if they have completed therapy for HCV and show sustained virologic remission (12 weeks or more)
Who cannot join
- Any currently active AIDS-defining illness per Category C conditions according to the CDC Classification System for HIV Infection, with the following exceptions:
- Limited cutaneous Kaposi's sarcoma not currently requiring systemic therapy
- Wasting syndrome due to HIV or any other AIDS-defining illness for which no therapeutic treatment is required OR the required treatment is not included in the list of prohibited medications
- Acute liver disease or any other active infection secondary to HIV requiring acute therapy
- History of progressive multifocal leukoencephalopathy (PML)
- Prior clinical John Cunningham virus (JCV) infection, history of JCV identified in cerebrospinal fluid, or presence of JCV antibodies at screening
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- Cirrhosis secondary to any cause
- Any immunomodulating therapy (excluding premedication steroid) within 4 weeks prior to the screening visit
- Prior malignancy within 2 years other than cutaneous basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, anal intraepithelial neoplasia, or cutaneous Kaposi's sarcoma
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Illinois at Chicago
Chicago, Illinois, 60612
University of California at San Francisco
San Francisco, California, 94110
About this study
Official title: A Phase 1, Single-blind, Dose-escalation Study to Assess the Safety and Tolerability of Brentuximab Vedotin (ADCETRIS®) in Subjects With Human Immunodeficiency Virus (HIV)
This study will test brentuximab vedotin to see if it is safe for people with human immunodeficiency virus (HIV) who have low CD4+ and have received antiretroviral therapy (ART) treatment. It will also see if brentuximab vedotin raises CD4+ counts. It will study the side effects of this drug as well. A side effect is anything a drug does to the body besides treating the disease.
In this study participants will be assigned randomly to a group. Participants will get either brentuximab vedotin or placebo. A placebo looks like the drug but does not contain any medicine in it. All participants will keep getting ART during the study.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- brentuximab vedotin, Placebo, ART
- Keywords
- HIV, Immunological Nonresponder, Seattle Genetics
- 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.
brentuximab vedotinDrug
Also called ADCETRIS
Given into the vein (IV; intravenously)
PlaceboDrug
Given by IV
ARTDrug
Daily use of a combination of HIV medicines
| Study group | Role | What they receive |
|---|---|---|
| Brentuximab vedotin + ART | Experimental | Brentuximab vedotin given on Day 1 and Day 15. ART will be given throughout the study. Receives: Drug: brentuximab vedotin; Drug: ART |
| Placebo + ART | Placebo comparator | Placebo given on Day 1 and Day 15. ART will be given throughout the study. Receives: Drug: Placebo; Drug: ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment
Measured: Through 30 days after last study treatment
Number of participants with laboratory abnormalities
Measured: Approximately 1 year
Number of participants with dose-limiting toxicities (DLTs) by dose level
Measured: Up to 30 days
Secondary outcomes (17)
Area under the concentration-time curve (AUC)
Pharmacokinetic (PK) Parameter
Measured: Approximately 4 months
Maximum concentration (Cmax)
PK Parameter
Measured: Approximately 4 months
Time to maximum concentration (Tmax)
PK Parameter
Measured: Approximately 4 months
Apparent terminal half-life (t1/2)
PK Parameter
Measured: Approximately 4 months
Trough concentration (Ctrough)
PK Parameter
Measured: Approximately 4 months
Incidence of antidrug antibodies (ADAs)
Measured: Approximately 4 months
Proportion of participants with CD4+ T-cell lymphocyte count >200 cells/µL
Measured: Approximately 1 year
Proportion of participants with CD4+ T-cell lymphocyte count >200 cells/µL, with a minimum increase of 50 cells/µL
Measured: Approximately 1 year
Duration of CD4+ T-cell lymphocyte count increases >200 cells/µL
The time from start of the first occurrence of CD4+ T-cell count increases to the level >200 cells/µL to the first occurrence of CD4+ T-cell count to the level <200 cells/µL
Measured: Approximately 1 year
Duration of CD4+ T-cell lymphocyte count increases >200 cells/µL with a minimum increase of 50 cells/µL
The time from start of the first occurrence of CD4+ T-cell count increases to the level >200 cells/µL to the first occurrence of CD4+ T-cell count to the level <200 cells/µL with a minimum increase of 50 cells/µL
Measured: Approximately 1 year
Change from baseline in CD4+ T-cell lymphocyte counts
The change from baseline in CD4+ T-cell lymphocyte counts will be summarized based on observed values.
Measured: Approximately 1 year
Change from baseline in CD4+ T cell percentage
The change from baseline in CD4+ T cell percentage will be summarized based on observed values.
Measured: Approximately 1 year
Change from baseline in CD8+ T-cell lymphocyte counts
The change from baseline CD8+ T-cell lymphocyte counts will be summarized based on observed values.
Measured: Approximately 1 year
Change from baseline in CD4:CD8 ratio
The change from baseline in CD4:CD8 ratio will be summarized.
Measured: Approximately 1 year
Change from baseline in Treg and other T-cell subsets
Measured: Approximately 6 months
Proportion of subjects with HIV viral load <50 copies/mL
The proportion of subjects with HIV viral load <50 copies/mL will be summarized.
Measured: Approximately 1 year
Proportion of subjects with fatal or non-fatal acquired immunodeficiency syndrome (AIDS) related opportunistic disease or death from any cause
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start31 Dec 2022 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Why it stopped: Study withdrawn due to low patient accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrei Shustov, MD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244473
- Sponsor's protocol ID
- SGN35-035
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-blind, Dose-escalation Study to Assess the Safety and Tolerability of Brentuximab Vedotin (ADCETRIS®) in Subjects With Human Immunodeficiency Virus (HIV)
- ClinicalTrials.gov ID
- NCT05244473
- Acronym / sponsor ID
- SGN35-035
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV, Immunological Nonresponder, Seattle Genetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to low patient accrual.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2022 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 17 Feb 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.
This study will test brentuximab vedotin to see if it is safe for people with human immunodeficiency virus (HIV) who have low CD4+ and have received antiretroviral therapy (ART) treatment. It will also see if brentuximab vedotin raises CD4+ counts. It will study the side effects of this drug as well. A side effect is anything a drug does to the body besides treating the disease.
In this study participants will be assigned randomly to a group. Participants will get either brentuximab vedotin or placebo. A placebo looks like the drug but does not contain any medicine in it. All participants will keep getting ART during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brentuximab vedotin + ART | Experimental | Drug: brentuximab vedotin, Drug: ARTBrentuximab vedotin given on Day 1 and Day 15. ART will be given throughout the study. |
| Placebo + ART | Placebo comparator | Drug: Placebo, Drug: ARTPlacebo given on Day 1 and Day 15. ART will be given throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV-1 seropositive with documentation of infection
- Immunological nonresponder, defined as:
- Life expectancy of >9 months.
- Participant is negative for hepatitis B, or if infected with hepatitis B, receiving anti-hepatitis B therapy
- Participants with a history of hepatitis C virus (HCV) are eligible if they have completed therapy for HCV and show sustained virologic remission (12 weeks or more)
Key exclusion criteria (9 listed)
- Any currently active AIDS-defining illness per Category C conditions according to the CDC Classification System for HIV Infection, with the following exceptions:
- Acute liver disease or any other active infection secondary to HIV requiring acute therapy
- History of progressive multifocal leukoencephalopathy (PML)
- Prior clinical John Cunningham virus (JCV) infection, history of JCV identified in cerebrospinal fluid, or presence of JCV antibodies at screening
- Cirrhosis secondary to any cause
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 |
|---|---|---|
| brentuximab vedotinAlso: ADCETRISGiven into the vein (IV; intravenously) | Drug | Brentuximab vedotin + ART |
| PlaceboGiven by IV | Drug | Placebo + ART |
| ARTDaily use of a combination of HIV medicines | Drug | Brentuximab vedotin + ART, Placebo + ART |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Through 30 days after last study treatment
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment
Number of participants with laboratory abnormalities
Time frame: Approximately 1 year
Number of participants with dose-limiting toxicities (DLTs) by dose level
Time frame: Up to 30 days
17 secondary outcomes
Area under the concentration-time curve (AUC)
Time frame: Approximately 4 months
Maximum concentration (Cmax)
Time frame: Approximately 4 months
Time to maximum concentration (Tmax)
Time frame: Approximately 4 months
Apparent terminal half-life (t1/2)
Time frame: Approximately 4 months
Trough concentration (Ctrough)
Time frame: Approximately 4 months
Incidence of antidrug antibodies (ADAs)
Time frame: Approximately 4 months
Proportion of participants with CD4+ T-cell lymphocyte count >200 cells/µL
Time frame: Approximately 1 year
Proportion of participants with CD4+ T-cell lymphocyte count >200 cells/µL, with a minimum increase of 50 cells/µL
Time frame: Approximately 1 year
Duration of CD4+ T-cell lymphocyte count increases >200 cells/µL
Time frame: Approximately 1 year
Duration of CD4+ T-cell lymphocyte count increases >200 cells/µL with a minimum increase of 50 cells/µL
Time frame: Approximately 1 year
Change from baseline in CD4+ T-cell lymphocyte counts
Time frame: Approximately 1 year
Change from baseline in CD4+ T cell percentage
Time frame: Approximately 1 year
Change from baseline in CD8+ T-cell lymphocyte counts
Time frame: Approximately 1 year
Change from baseline in CD4:CD8 ratio
Time frame: Approximately 1 year
Change from baseline in Treg and other T-cell subsets
Time frame: Approximately 6 months
Proportion of subjects with HIV viral load <50 copies/mL
Time frame: Approximately 1 year
Proportion of subjects with fatal or non-fatal acquired immunodeficiency syndrome (AIDS) related opportunistic disease or death from any cause
Time frame: Approximately 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
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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.
Andrei Shustov, MD study director
Seagen Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing brentuximab vedotin and ART in people with Human Immunodeficiency Virus, run by Seagen Inc. at 2 sites 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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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 adverse events (AEs) (time frame: Through 30 days after last study treatment). The study lists 3 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 14 Feb 2023.