NCT03588715: BEAT-2

Peg-Interferon Alpha 2b Combined With Two Intravenous Broadly HIV-1 Neutralizing Antibodies 3BNC117 and 10-1074 (BEAT-2)

Status unknown Phase 1 Last updated 25 June 2021

What this trial tests

Phase 1 trial testing Pegylated Interferon alpha 2b (peg-IFN-α2b) in HIV in 15 participants. Status unknown.

Timeline

18 June 2020

Primary endpoint
31 December 2021

30 October 2022

Quick facts

Lead sponsor	Luis Montaner
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	18 June 2020
Primary completion	31 December 2021
Estimated completion	30 October 2022
Sites	2 locations across United States

Drugs / interventions tested

• Pegylated Interferon alpha 2b (peg-IFN-α2b) — full drug profile →
• 3BNC117 + 10-1074 — full drug profile →

Conditions studied

• HIV — all drugs for HIV →
• HIV/AIDS — all drugs for HIV/AIDS →
• HIV-1 Infection — all drugs for HIV-1 Infection →

Sponsor

Luis Montaner — full company profile →

Who can join

18 and older, any sex, with HIV or HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate the safety, tolerability and innate immune mechanisms activation following administration of the combination of Pegylated Interferon alpha 2b (peg-IFN-α2b) with two broadly neutralizing antibodies (3BNC117 and 10-1074) in the setting of well-controlled HIV infection with antiretroviral treatment and a monitored analytical treatment interruption. The current proposal builds on previous experience using interferon alpha, 3BNC117 and 10-1074 alone in separate clinical trials that included a closely monitored analytical treatment interruption. The hypothesis is that the joint administration of peg-IFN-α2b with 3BNC117 and 10-1074 will be more effective than either intervention separately in suppressing HIV viremia during 8 weeks of analytical treatment interruption (Step 4) and reducing integrated HIV DNA in blood and tissue when measured during an analytical treatment interruption in patients with well-controlled HIV infection.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Restriction Factors: From Intrinsic Viral Restriction to Shaping Cellular Immunity Against HIV-1.
   Colomer-Lluch M, Ruiz A, Moris A, Prado JG. · · 2018 · cited 138× · PMID 30574147 · DOI 10.3389/fimmu.2018.02876
2. Advances toward Curing HIV-1 Infection in Tissue Reservoirs.
   Henderson LJ, Reoma LB, Kovacs JA, Nath A. · · 2020 · cited 52× · PMID 31694954 · DOI 10.1128/jvi.00375-19
3. Broadly neutralizing monoclonal antibodies for HIV prevention.
   Miner MD, Corey L, Montefiori D. · · 2021 · cited 34× · PMID 34806308 · DOI 10.1002/jia2.25829
4. The Use of Broadly Neutralizing Antibodies (bNAbs) in HIV-1 Treatment and Prevention.
   Thavarajah JJ, Hønge BL, Wejse CM. · · 2024 · cited 31× · PMID 38932203 · DOI 10.3390/v16060911
5. Can Broadly Neutralizing HIV-1 Antibodies Help Achieve an ART-Free Remission?
   Hsu DC, Mellors JW, Vasan S. · · 2021 · cited 30× · PMID 34322136 · DOI 10.3389/fimmu.2021.710044
6. The RIO trial: rationale, design, and the role of community involvement in a randomised placebo-controlled trial of antiretroviral therapy plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) in participants diagnosed with recent HIV infection-study protocol
   Lee MJ, Collins S, Babalis D, Johnson N, et al · · 2022 · cited 24× · PMID 35382844 · DOI 10.1186/s13063-022-06151-w
7. Analytical Treatment Interruption in HIV Trials: Statistical and Study Design Considerations.
   Zheng L, Tierney C, Bosch RJ. · · 2021 · cited 22× · PMID 34213731 · DOI 10.1007/s11904-021-00569-8
8. Clinical trials of broadly neutralizing monoclonal antibodies in people living with HIV - a review.
   Mahomed S, Pillay K, Hassan-Moosa R, Galvão BPGV, et al · · 2025 · cited 20× · PMID 40189566 · DOI 10.1186/s12981-025-00734-8