UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
NCT ID: NCT04406727
Last Updated: 2023-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
50 participants
INTERVENTIONAL
2023-12-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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UB-421
2-arm Comparison Phase: UB-421(25 mg/kg, every 2 weeks) in combination with ARV
Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).
UB-421
UB-421 in combination with their ARV
Antiretroviral (ARV)
Antiretroviral (ARV)
Placebo
2-arm Comparison Phase: Placebo in combination with ARV
Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).
Antiretroviral (ARV)
Antiretroviral (ARV)
Interventions
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UB-421
UB-421 in combination with their ARV
Antiretroviral (ARV)
Antiretroviral (ARV)
Eligibility Criteria
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Inclusion Criteria
2. Have a history of at least 6 months on antiretroviral treatment
3. Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks before Screening
Exclusion Criteria
2. Females who are pregnant
3. Any vaccination within 2 weeks prior to the Screening
4. Any prior exposure to UB-421
20 Years
ALL
No
Sponsors
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United BioPharma
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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UBP-A308-HIV
Identifier Type: -
Identifier Source: org_study_id
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