Summary
Enfuvirtide 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 ClinicalTrials.gov lists 8 registered trials linking Enfuvirtide to HIV/AIDS: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00326963). The largest enrolment is 224 participants (NCT02302547). Registration activity spans 2002 to 2014. The literature layer holds 10 publications for this pair: 2 meta-analyses, 3 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2006 to 2020. 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 | 77.0 (trials 30.0, literature 27.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 7 completed, 1 other |
| Linked publications | 10 (5 clinical trial publications, 3 randomised controlled trial publications, 2 meta-analyses) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00925756 | CCR5 Inhibitor Treatment Intensification on CD4+ T-cell Recovery 2008 | completed | Phase 4 | 32 |
| NCT00192660 | HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001) 2003 | completed | Phase 4 | 80 |
| NCT02569502 | A Study of Enfuvirtide (Fuzeon) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection 2005 | completed | Phase 4 | 6 |
| NCT00326963 | BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1. 2006 | completed | Phase 4 | 142 |
| NCT00488059 | A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients 2007 | terminated | Phase 4 | 29 |
| NCT02302547 | Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy 2014 | completed | Phase 3 | 224 |
| NCT00050856 | Fuzeon (Enfuvirtide) Early Access Program for Patients With HIV-1 Infection 2002 | completed | Phase 3 | 5 |
| NCT00051831 | Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults 2003 | completed | Not applicable | 19 |
Published literature
- Clinical trial publication Allogeneic bone marrow transplantation with post-transplant cyclophosphamide for patients with HIV and haematological malignancies: a feasibility studyDurand CM, Capoferri AA, Redd AD et al. · The lancet. HIV · 2020 · PMID 32649866
- Clinical trial publication Metabolic, mitochondrial, renal and hepatic safety of enfuvirtide and raltegravir antiretroviral administration: Randomized crossover clinical trial in healthy volunteersBarroso S, Morén C, González-Segura À et al. · PloS one · 2019 · PMID 31120908
- Clinical trial publication Incidence and risk factors for liver enzymes elevations in highly treatment-experienced patients switching from enfuvirtide to raltegravir: a sub-study of the ANRS-138 EASIER trialde Castro N, Braun J, Charreau I et al. · AIDS research and therapy · 2016 · PMID 27042193
- Clinical trial publication Assessment of etravirine resistance in HIV-1-infected paediatric patients using population and deep sequencing: final results of the PIANO studyTambuyzer L, Thys K, Hoogstoel A et al. · Antiviral therapy · 2016 · PMID 26566161
- Clinical trial publication Safety and Efficacy of Combination Antiretroviral Therapy in Human Immunodeficiency Virus-Infected Adults Undergoing Autologous or Allogeneic Hematopoietic Cell Transplantation for Hematologic MalignanciesJohnston C, Harrington R, Jain R et al. · Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2016 · PMID 26265463
- Randomized controlled trial Pharmacokinetics of sifuvirtide in treatment-naive and treatment-experienced HIV-infected patientsMeng Q, Dong T, Chen X et al. · Journal of pharmaceutical sciences · 2014 · PMID 25291974
- Randomized controlled trial Decreases in inflammatory and coagulation biomarkers levels in HIV-infected patients switching from enfuvirtide to raltegravir: ANRS 138 substudySilva EF, Charreau I, Gourmel B et al. · The Journal of infectious diseases · 2013 · PMID 23801606
- Randomized controlled trial Intensification of antiretroviral therapy through addition of enfuvirtide in naive HIV-1-infected patients with severe immunosuppression does not improve immunological response: results of a randomized multicenter trial (ANRS 130 Apollo)Joly V, Fagard C, Grondin C et al. · Antimicrobial agents and chemotherapy · 2013 · PMID 23165467
- Meta-analysis Efficacy of new antiretroviral drugs in treatment-experienced HIV-infected patients: a systematic review and meta-analysis of recent randomized controlled trialsPichenot M, Deuffic-Burban S, Cuzin L et al. · HIV medicine · 2012 · PMID 22107456
- Meta-analysis Concomitant use of an active boosted protease inhibitor with enfuvirtide in treatment-experienced, HIV-infected individuals: recent data and consensus recommendationsYoule M, Staszweski S, Clotet B et al. · HIV clinical trials · 2006 · PMID 16798623
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 Enfuvirtide approved for HIV/AIDS?
Enfuvirtide 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 Enfuvirtide in clinical trials for HIV/AIDS?
ClinicalTrials.gov lists 8 registered trials linking Enfuvirtide to HIV/AIDS: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00326963). The largest enrolment is 224 participants (NCT02302547). Registration activity spans 2002 to 2014.
What does the evidence show for Enfuvirtide in HIV/AIDS?
Enfuvirtide 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.