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HIV-1-infectionPhase 1NCT05890963

10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults

A Phase 1 study testing ART, 10E8.4/iMab and VRC07-523LS in people with HIV-1-infection, run by David Ho at 1 site in Tanzania.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an open-label phase 1b clinical trial enrolling people living with HIV (PLWH) who are antiretroviral therapy (ART)-naïve or have not been on ART for > 24 weeks. This study will enroll PLWH to assess the safety, tolerability, and antiviral effect of bispecific and long-acting bNAbs, alone and in combination. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
HIV-1-infection
What is being tested?
ART, 10E8.4/iMab and VRC07-523LS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTanzania
Study dates
28 Nov 2023to May 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Able to read and write in Kiswahili and/or English
  • Able and willing to provide written informed consent
  • Passes Test of Understanding (TOU)
  • Aged 18-50 years, inclusive
  • Antiretroviral Therapy (ART)-naïve or no ART for > 24 weeks at the time of screening
  • HIV RNA 1,000-100,000 copies/mL
Show all 14Show fewer
  • CD4 ≥ 500 cells/mm3
  • Laboratory criteria at screening within protocol-specified limits for blood, chemistry and urinalysis
  • Willing and able to participate in study visits and procedures for up to 50 weeks
  • Willing and able to begin ART as directed during the study
  • Willing and able to use barrier protection during sex with partners without HIV or partners with unknown HIV status throughout Step 1 and until viral suppression <200 copies/mL is confirmed in Step 2
  • Willing and able to adhere to the following contraception requirements:
  • Participants who are able to become pregnant must agree to use at least one method of highly effective contraception if participating in sexual activity that could lead to pregnancy. This must begin at least 14 days prior to study enrollment.
  • Participants who engage in sexual activity that could lead to their partner becoming pregnant and who are of reproductive potential must agree to use a barrier method of contraception to avoid pregnancy in a sexual partner of reproductive potential. The barrier method must be used for the duration of the study.

Who cannot join

  • Weight >100 kg
  • Previous receipt of humanized or human monoclonal antibody whether licensed or investigational (other than for the prevention and/or treatment of SARS-CoV2/COVID-19)
  • History of viral failure on two or more ART regimens
  • Planned or anticipated need for enfuvirtide, maraviroc, fostemsavir, or ibalizumab for antiretroviral therapy.
  • AIDS-defining illness, as enumerated by the WHO Stage 3 or 4, within the six months prior to enrollment
  • Ongoing oral thrush
Show all 20Show fewer
  • Active injection or other recreational drug use within the previous 12 months that, in the opinion of the investigator, would impede the participant's ability to safely and consistently adhere to the study protocol
  • History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis in the 2 years prior to enrollment.
  • History of chronic urticaria requiring daily treatment
  • Known active hepatitis B virus infection or positive hepatitis B surface antigen at any time in the past
  • Known active hepatitis C virus infection or positive hepatitis C antibody at any time in the past
  • Untreated syphilis
  • Estimated GFR < 50 mL/min within the past 90 days
  • Pregnant or breast-feeding
  • Receipt of licensed vaccine or other investigational study agent within 28 days prior to enrollment or any past participation in an investigational HIV vaccine study with receipt of active product
  • Current or planned participation in another interventional clinical trial during the study period, including clinical trials of investigational new drugs or investigating a new application for an approved medication
  • Chronic or recurrent use of medications that modify host immune response, such as oral steroids, parenteral steroids, or cancer chemotherapy (note: locally-acting medications-such as inhaled, topical, or intra-articular steroids-are allowed)
  • Any other chronic or clinically significant medical condition that in the opinion of the investigator would jeopardize the safety or rights of the participant including, but not limited to: diabetes mellitus type I, chronic hepatitis, renal failure; OR clinically significant forms of: drug or alcohol abuse, mental illness, severe asthma, autoimmune disease, decompensated psychiatric disorders, hypertension, heart disease, or cancer
  • Any medications that, in the opinion of the investigator, would preclude intramuscular injections
  • Study site employee

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

  • National Institute for Medical Research-Mbeya Medical Resarch Center

    Mbeya

Other trials in Tanzania

About this study

Official title: Phase 1b Single Dose Clinical Trial of a Novel Long-Acting Bispecific Antibody in People With HIV to Inform Development for HIV Pre- and Post-Exposure Prophylaxis

This is an open-label phase 1b clinical trial enrolling people living with HIV (PLWH) who are antiretroviral therapy (ART)-naïve or have not been on ART for > 24 weeks. This study will enroll PLWH to assess the safety, tolerability, and antiviral effect of bispecific and long-acting bNAbs, alone and in combination. The study will be conducted as a single center study at National Institute for Medical Research-Mbeya Medical Research Center (NIMR-MMRC) in Mbeya, Tanzania.

20 PLWH will be sequentially enrolled into one of 5 arms, each arm comprised of 4 participants. Sequential enrollment will occur in the following order:

  • Arm 1 will receive standard daily oral ART.
  • Arm 2 will receive a single dose of 10E8.4/iMab 600mg intravenous injection (IV).
  • Arm 3 will receive a single dose of 10E8.4/iMab 600mg intramuscular injection (IM).
  • Arm 4 will receive a single dose of 10E8.4/iMab 1800mg IV.
  • Arm 5 will receive a single dose of combination therapy with both 10E8.4/iMab 1800mg IV and VRC07-523LS 1200mg IV.
Read the detailed description

Although global initiatives have made great strides in controlling the human immunodeficiency virus (HIV) pandemic, HIV and acquired immune deficiency syndrome (AIDS) continue to impact the lives and livelihoods of a significant portion of the population. In 2019, 38 million individuals were living with HIV and 690,000 died of AIDS-related causes. Despite extensive global efforts for disease control over the last 20 years, 1.7 million individuals contract HIV annually. Antiretroviral therapy (ART) reduces morbidity and mortality associated with HIV by suppressing viral replication but does not eradicate infection. There are barriers to universal ART use that include toxicities, costs, drug resistance, and the need for lifelong adherence. To overcome these barriers, HIV broadly neutralizing antibodies (bNAbs) represent a novel approach to HIV prevention and treatment.

The primary endpoint of change in viral load will be assessed at day 14. Participants will then transition to Step 2, during which all participants will take standard daily oral ART and have viral load monitored through Step 2 week 48.

Conditions
HIV-1-infection
Being tested
ART, 10E8.4/iMab, VRC07-523LS
Keywords
Antiretroviral therapy (ART), VRC07-523LS, 10E8.4/iMab, Monoclonal antibody, Bispecific antibody, Broadly neutralizing antibodies, Viral suppression, Ibalizumab, 10E8

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARTDrug

    Also called antiretroviral therapy

    ART is a combination of three or more drugs from different classes of antiretroviral medication.

  • 10E8.4/iMabDrug

    Also called ibalizumab

    10E8.4/iMab is an engineered bispecific antibody with two arms combined into a single molecule that exhibits synergistic enhancement of antiviral activity. 10E8.4/iMab will be administered IV at the 600mg or 1800mg dose or IM at 600mg dose to participants in Step 1 per the Schedule of Events (SOE) based on the arm the participant is assigned.

  • VRC07-523LSDrug

    Also called VRC01 variant

    VRC07-523LS is an engineered variant of VRC01, a bNAb that targets the CD4 binding site of the HIV-1 envelope. VRC07-523LS will be administered IV at the 1200mg dose to participants in Step 1 per the SOE.

Study groups in NCT05890963
Study groupRoleWhat they receive
Arm 1: Oral ARTActive comparatorParticipants will receive standard daily oral ART.
Receives: Drug: ART
Arm 2: 10E8.4/iMab 600mg IV.ExperimentalParticipants will receive a single dose of 10E8.4/iMab 600mg IV.
Receives: Drug: 10E8.4/iMab
Arm 3: 10E8.4/iMab 600mg IM.ExperimentalParticipants will receive a single dose of 10E8.4/iMab 600mg IM.
Receives: Drug: 10E8.4/iMab
Arm 4:10E8.4/iMab 1800mg IV.ExperimentalParticipants will receive a single dose of 10E8.4/iMab 1800mg IV.
Receives: Drug: 10E8.4/iMab
Arm 5: Combination 10E8.4/iMab and VRC07-523LS therapyExperimentalParticipants will receive a single dose of combination therapy with both 10E8.4/iMab 1800mg IV. and VRC07-523LS 1200mg IV.
Receives: Drug: 10E8.4/iMab; Drug: VRC07-523LS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Grade 3 or higher antibody-related reactogenicity and adverse events

    Includes potentially life-threatening, or fatal events.

    Measured: Up to Week 48 in Step 2

  2. Change in plasma HIV RNA from day 0 to day 14

    Viral RNA copies/mL will be measured.

    Measured: Day 0 and Day 14 in Step 1

  3. Proportion of participants with HIV RNA < 50 copies/mL at day 14

    Percentage of participants will be calculated.

    Measured: Up to Day 14 in Step 1

Secondary outcomes (11)

  1. Proportions of participants with HIV RNA <50 copies/mL

    Percentage of participants will be calculated.

    Measured: Up to Week 48 in Step 2

  2. Proportions of participants with HIV RNA < 200 copies/mL

    Percentage of participants will be calculated.

    Measured: Up to Week 48 in Step 2

  3. Proportions of participants with HIV RNA <1000 copies/mL

    Percentage of participants will be calculated.

    Measured: Up to Week 48 in Step 2

  4. Peripheral HIV RNA

    Serum level of viral RNA (copies/mL) will be measured.

    Measured: Up to Week 48 in Step 2

  5. Plasma level of 10E8.4/iMab

    Serum level of 10E8.4/iMab (ug/mL) will be measured.

    Measured: Up to Week 48 in Step 2

  6. Plasma level of VRC07-523LS

    Serum level of VRC07-523LS (ug/mL) will be measured.

    Measured: Up to Week 48 in Step 2

  7. CD4 receptor occupancy

    The percentage of CD4 cells that bind to 10E8.4/iMab will be measured.

    Measured: Up to Week 48 in Step 2

  8. HIV reservoir size

    Will measure HIV DNA in copies/million cells.

    Measured: Up to Week 48 in Step 2

  9. Neutralization sensitivity of 10E8.4/iMab

    Half-maximal inhibitory concentration (IC50) will be measured.

    Measured: Up to Week 48 in Step 2

  10. Neutralization sensitivity of VRC07-523LS

    Half-maximal inhibitory concentration (IC50) will be measured.

    Measured: Up to Week 48 in Step 2

  11. Presence of anti-bNAb antibodies

    The anti-drug antibody titer in serum will be measured.

    Measured: Up to Week 48 in Step 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2023
  2. Study start28 Nov 2023
  3. Primary completion14 Apr 2026
  4. Study completionMay 2027 (estimated)

Resources

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
Non-randomised
Intervention model
Sequential
Model description
Participants are assigned to 1 to 5 arm sequentially.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05890963
Sponsor's protocol ID
AAAU5207
Other IDs
W81XWH-18-2-0040, RV584
Status last verified
May 2026
First submitted
26 May 2023
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie results published in any manuscript or otherwise disseminated will be shared. Sharing would occur only after deidentification and with researchers who provide a methodologically sound proposal to analyze the data and secure required regulatory and ethical approvals through appropriate institutions. Deidentified data may also be made available through public data repositories.

Publications

  • Huang Y, Yu J, Lanzi A, Yao X, Andrews CD, Tsai L, Gajjar MR, Sun M, Seaman MS, Padte NN, Ho DD. Engineered Bispecific Antibodies with Exquisite HIV-1-Neutralizing Activity. Cell. 2016 Jun 16;165(7):1621-1631. doi: 10.1016/j.cell.2016.05.024.

    PubMed 27315479

  • Mahomed S, Garrett N, Capparelli EV, Osman F, Harkoo I, Yende-Zuma N, Gengiah TN, Archary D, Samsunder N, Baxter C, Mkhize NN, Modise T, Carlton K, McDermott A, Moore PL, Karim QA, Barouch DH, Fast PE, Mascola JR, Ledgerwood JE, Morris L, Abdool Karim SS. Safety and Pharmacokinetics of Monoclonal Antibodies VRC07-523LS and PGT121 Administered Subcutaneously for Human Immunodeficiency Virus Prevention. J Infect Dis. 2022 Aug 26;226(3):510-520. doi: 10.1093/infdis/jiac041.

    PubMed 35134995

  • Huang J, Ofek G, Laub L, Louder MK, Doria-Rose NA, Longo NS, Imamichi H, Bailer RT, Chakrabarti B, Sharma SK, Alam SM, Wang T, Yang Y, Zhang B, Migueles SA, Wyatt R, Haynes BF, Kwong PD, Mascola JR, Connors M. Broad and potent neutralization of HIV-1 by a gp41-specific human antibody. Nature. 2012 Nov 15;491(7424):406-12. doi: 10.1038/nature11544. Epub 2012 Sep 18.

    PubMed 23151583

  • Burkly LC, Olson D, Shapiro R, Winkler G, Rosa JJ, Thomas DW, Williams C, Chisholm P. Inhibition of HIV infection by a novel CD4 domain 2-specific monoclonal antibody. Dissecting the basis for its inhibitory effect on HIV-induced cell fusion. J Immunol. 1992 Sep 1;149(5):1779-87.

    PubMed 1380539

  • Jacobson JM, Kuritzkes DR, Godofsky E, DeJesus E, Larson JA, Weinheimer SP, Lewis ST. Safety, pharmacokinetics, and antiretroviral activity of multiple doses of ibalizumab (formerly TNX-355), an anti-CD4 monoclonal antibody, in human immunodeficiency virus type 1-infected adults. Antimicrob Agents Chemother. 2009 Feb;53(2):450-7. doi: 10.1128/AAC.00942-08. Epub 2008 Nov 17.

    PubMed 19015347

  • Finzi D, Hermankova M, Pierson T, Carruth LM, Buck C, Chaisson RE, Quinn TC, Chadwick K, Margolick J, Brookmeyer R, Gallant J, Markowitz M, Ho DD, Richman DD, Siliciano RF. Identification of a reservoir for HIV-1 in patients on highly active antiretroviral therapy. Science. 1997 Nov 14;278(5341):1295-300. doi: 10.1126/science.278.5341.1295.

    PubMed 9360927

  • Wolfe D, Carrieri MP, Shepard D. Treatment and care for injecting drug users with HIV infection: a review of barriers and ways forward. Lancet. 2010 Jul 31;376(9738):355-66. doi: 10.1016/S0140-6736(10)60832-X.

    PubMed 20650513

  • Jaworski JP, Cahn P. Preventive and therapeutic features of broadly neutralising monoclonal antibodies against HIV-1. Lancet HIV. 2018 Dec;5(12):e723-e731. doi: 10.1016/S2352-3018(18)30174-7. Epub 2018 Sep 21.

    PubMed 30245003

  • Chun TW, Stuyver L, Mizell SB, Ehler LA, Mican JA, Baseler M, Lloyd AL, Nowak MA, Fauci AS. Presence of an inducible HIV-1 latent reservoir during highly active antiretroviral therapy. Proc Natl Acad Sci U S A. 1997 Nov 25;94(24):13193-7. doi: 10.1073/pnas.94.24.13193.

    PubMed 9371822

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ART, 10E8.4/iMab and VRC07-523LS in people with HIV-1-infection, run by David Ho at 1 site in Tanzania.

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 14 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. 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. 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?

This study is still under way. Results are not available in the source record yet.

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 Grade 3 or higher antibody-related reactogenicity and adverse events (time frame: Up to Week 48 in Step 2). 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?

On the ClinicalTrials.gov record for NCT05890963, which also lists 9 linked publications.

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 2 Jun 2026.

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