PRO-542
Also known as: CD4-IgG2, PRO542, Tetrameric CD4-IgG2
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Summary
PRO-542 (CD4-IgG2) is a recombinant fusion protein combining four CD4 domains with human IgG2 heavy and light chains, giving it tetravalent binding to HIV-1 gp120. It was investigated as an HIV-1 entry inhibitor in both adults and pediatric patients with HIV-1 infection. Clinical trials demonstrated antiviral activity and good tolerability, but development was not advanced to regulatory approval, partly due to the emergence of small-molecule entry inhibitors.
Mechanism of Action
PRO-542 is a tetravalent CD4-IgG2 fusion protein that mimics the HIV-1 gp120 binding site on CD4. It competitively inhibits HIV-1 entry by binding with high affinity to gp120 on the viral surface, preventing virus attachment to host cell CD4 receptors and blocking subsequent coreceptor engagement and membrane fusion.
Routes of Administration
Goals & Uses
- Pediatric HIV-1 treatmentAntiviral TherapyLow
- Salvage therapy for treatment-experienced HIV patientsAntiviral TherapyLow
- HIV-1 entry inhibitionMechanism Based Viral SuppressionModerate
- HIV-1 viral load reductionAntiviral EfficacyModerate
Contraindications
- Hypersensitivity to CD4-IgG2 or IgG2-based biologicsImmunologicHigh
Adverse Effects
- Flu-like symptomsSystemic/ImmunologicalUncommon
- Injection site reactionsLocalCommon
- HeadacheNeurologicUncommonPain in the head or upper neck
- Immunogenicity / anti-drug antibodiesImmunologicUncommon
Drug Interactions
- Antiretroviral agents (combination ART)Low
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric patients < 2 yearsAgeRelative
- Renal or hepatic impairmentOrgan DysfunctionRelative
Regulatory Status
- European UnionInvestigationalNo marketing authorization granted by EMA
- United StatesInvestigationalStudied under IND; Phase I/II completed; never approved by FDA
- United KingdomInvestigationalNo regulatory approval in the UK
PRO-542 was studied in Phase I/II clinical trials. It was never submitted for or granted regulatory approval by FDA, EMA, or other agencies. It remains an investigational compound. Developed by Progenics Pharmaceuticals.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is PRO-542?
PRO-542 (CD4-IgG2) is a recombinant fusion protein combining four CD4 domains with human IgG2 heavy and light chains, giving it tetravalent binding to HIV-1 gp120. It was investigated as an HIV-1 entry inhibitor in both adults and pediatric patients with HIV-1 infection. Clinical trials demonstrated antiviral activity and good tolerability, but development was not advanced to regulatory approval, partly due to the emergence of small-molecule entry inhibitors.
What is PRO-542 used for?
PRO-542 is educationally associated with: Pediatric HIV-1 treatment, Salvage therapy for treatment-experienced HIV patients, HIV-1 entry inhibition, HIV-1 viral load reduction. Educational only — not medical advice.
How is PRO-542 administered?
Recorded routes of administration: Intravenous, Subcutaneous.
What are the potential side effects of PRO-542?
Reported adverse effects include: Flu-like symptoms, Injection site reactions, Headache, Immunogenicity / anti-drug antibodies. This list is not exhaustive — consult a qualified clinician.
Who should avoid PRO-542?
Recorded contraindications: Hypersensitivity to CD4-IgG2 or IgG2-based biologics. Consult a qualified clinician before use.