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Monoclonal Antibodies

ART for HIV/AIDS

Phase 1
Waitlist Available
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1 year
Awards & highlights

Study Summary

This trial will test the safety of brentuximab vedotin for people with HIV who have low CD4+ and have received antiretroviral therapy (ART) treatment.

Eligible Conditions
  • HIV/AIDS

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events (AEs)
Number of participants with dose-limiting toxicities (DLTs) by dose level
Number of participants with laboratory abnormalities
Secondary outcome measures
Apparent terminal half-life (t1/2)
Area under the concentration-time curve (AUC)
Change from baseline in CD4+ T cell percentage
+14 more

Side effects data

From 2021 Phase 1 & 2 trial • 30 Patients • NCT03707977
83%
Cough
67%
Haemoglobin decreased
33%
Pyrexia
33%
Viral upper respiratory tract infection
33%
Rash
33%
Decreased appetite
33%
Abdominal pain
17%
Chills
17%
Urinary tract infection
17%
Buttock injury
17%
Viral rash
17%
Tinea capitis
17%
Eye discharge
17%
Fungal skin infection
17%
Blood glucose increased
17%
Conjunctivitis
17%
Rash macular
17%
Rhinitis
17%
Dermatitis allergic
17%
Pain in extremity
17%
Rhinorrhoea
17%
Blood pressure increased
17%
Neutrophil count decreased
17%
Eczema
17%
Skin plaque
17%
Diarrhoea
17%
Abscess limb
17%
Vomiting
17%
Blood creatinine increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
PK Step (ART + VRC01LS)
PK Step (ART + 10-1074)
Step 1 (ART + VRC01LS + 10-1074)
Step 2 (VRC01LS + 10-1074 Only)
Step 3 (ART Only)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Brentuximab vedotin + ARTExperimental Treatment2 Interventions
Brentuximab vedotin given on Day 1 and Day 15. ART will be given throughout the study.
Group II: Placebo + ARTPlacebo Group2 Interventions
Placebo given on Day 1 and Day 15. ART will be given throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ART
2008
Completed Phase 4
~7770
brentuximab vedotin
2010
Completed Phase 3
~1880

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
207 Previous Clinical Trials
69,157 Total Patients Enrolled
Andrei Shustov, MDStudy DirectorSeagen Inc.
2 Previous Clinical Trials
1,129 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned ART as a legitimate form of treatment?

"Taking into account the limited data regarding efficacy and safety, our team at Power gave ART a score of 1 on the scale from 1 to 3."

Answered by AI

How many volunteers are involved in this research endeavor?

"Affirmative. Clinicaltrials.gov contains proof that this medical trial, which was posted on October 31st 2022, is actively recruiting new participants. 48 individuals need to be sourced from 3 different medical locations."

Answered by AI

Are there any enrollment opportunities for this clinical trial currently available?

"According to the data on clinicaltrials.gov, this medical trial is presently enrolling patients. This study was first advertised on October 31st 2022 and saw its last update occur in September 30th of 2022."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
How old are they?
18 - 65
What site did they apply to?
University of Illinois at Chicago
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Safety Study of Brentuximab Vedotin in Participants With HIV
2022. "A Safety Study of Brentuximab Vedotin in Participants With HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05244473.
~0 spots leftby May 2024
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