Albuvirtide in Combination With 3BNC117 in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection

Phase 2

Waitlist Available

Research Sponsored by Frontier Biotechnologies 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 week 25/eot

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment combining two drugs, albuvirtide and 3BNC117, for people with HIV-1 who are not responding to their current medications. The treatment aims to reduce the virus in the body by preventing it from entering cells and helping the immune system fight it. The study will evaluate how well this combination works and how safe it is for patients.

Eligible Conditions

HIV/AIDS

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 25/eot

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 25/eot

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 25/eot for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants with ≥0.5 log10 reduction in HIV-1 RNA viral load from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7.

Secondary study objectives

Mean change in CD4+/CD8+ T cell count from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7.

CD8-Positive T-Lymphocytes

Mean change in HIV-1 RNA levels (log10 copies/mL) during the course of Treatment Phase

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