Summary
Ibalizumab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in HIV/AIDS would be drug repurposing rather than first-in-human development. This does not mean it is approved for HIV/AIDS. ClinicalTrials.gov lists 8 registered trials linking Ibalizumab to HIV/AIDS: 1 is active or not yet recruiting; 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT02707861). The largest enrolment is 113 participants (NCT00784147). Registration activity spans 2004 to 2023. The literature layer holds 7 publications for this pair: 3 systematic reviews and 4 clinical trial publications. Publication years run from 2009 to 2024. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for HIV/AIDS ranks 249 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous elite control (natural viremic suppression without ART) in <1% of people living with HIV; untreated, median time to AIDS ~10 years; viral rebound within weeks of ART interruption in 99%+ of patients.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 63.5 (trials 26.5, literature 17.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 1 active / not yet recruiting, 5 completed, 2 other |
| Linked publications | 7 (4 clinical trial publications, 3 systematic reviews) |
| Agent type | Biologic |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT02707861 | Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1 2016 | completed | Phase 3 | 79 |
| NCT02475629 | Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV 2015 | completed | Phase 3 | 40 |
| NCT03913195 | Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection 2019 | completed | Phase 3 | 43 |
| NCT00784147 | Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1 2008 | completed | Phase 2 | 113 |
| NCT00089700 | TNX-355 With Optimized Background Therapy (OBT) in Treatment-Experienced Subjects With HIV-1 2004 | status unknown | Phase 2 | 80 |
| NCT05890963 | 10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults 2023 | active, not recruiting | Phase 1 | 20 |
| NCT01292174 | Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers 2011 | completed | Phase 1 | 25 |
| NCT02028819 | Compassionate Use of Ibalizumab for the Treatment of HIV Infection 2012 | no_longer_available | Not applicable | — |
Published literature
- Clinical trial publication Efficacy and Safety of 2 Fixed Doses of Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced HIV-Positive IndividualsDeJesus E, Towner WJ Jr, Gathe JC et al. · Journal of acquired immune deficiency syndromes (1999) · 2024 · PMID 39250331
- Systematic review Pharmacokinetics of Antiretroviral Drugs in Older People Living with HIV: A Systematic ReviewToledo T, Castro T, Oliveira VG et al. · Clinical pharmacokinetics · 2023 · PMID 37561283
- Systematic review Indirect Treatment Comparisons of Lenacapavir Plus Optimized Background Regimen Versus Other Treatments for Multidrug-Resistant Human Immunodeficiency VirusChatzidaki I, Curteis T, Luedke H et al. · Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2023 · PMID 36566886
- Systematic review Comparative Efficacy and Safety of Fostemsavir in Heavily Treatment-Experienced People With HIV-1Anderson SJ, van Doornewaard A, Turner M et al. · Clinical therapeutics · 2022 · PMID 35610081
- Clinical trial publication Efficacy, Pharmacokinetics, and Safety Over 48 Weeks With Ibalizumab-Based Therapy in Treatment-Experienced Adults Infected With HIV-1: A Phase 2a StudyGathe JC, Hardwicke RL, Garcia F et al. · Journal of acquired immune deficiency syndromes (1999) · 2021 · PMID 33427765
- Clinical trial publication Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1Emu B, Fessel J, Schrader S et al. · The New England journal of medicine · 2018 · PMID 30110589
- Clinical trial publication 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 adultsJacobson JM, Kuritzkes DR, Godofsky E et al. · Antimicrobial agents and chemotherapy · 2009 · PMID 19015347
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Ibalizumab approved for HIV/AIDS?
Ibalizumab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in HIV/AIDS would be drug repurposing rather than first-in-human development. This does not mean it is approved for HIV/AIDS. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Ibalizumab in clinical trials for HIV/AIDS?
ClinicalTrials.gov lists 8 registered trials linking Ibalizumab to HIV/AIDS: 1 is active or not yet recruiting; 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT02707861). The largest enrolment is 113 participants (NCT00784147). Registration activity spans 2004 to 2023.
What does the evidence show for Ibalizumab in HIV/AIDS?
Ibalizumab has both completed registered trials and synthesis-level publications linked to HIV/AIDS. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.