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A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute/Early HIV-1 Infection

ConditionHIV-1-infection
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

The purpose of this study is to evaluate the safety, tolerability, and efficacy of combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability and willingness of participant to provide informed consent.

A negative HIV Ab or HIV Ag/Ab Combination Assay and a detectable HIV-1 RNA (qualitative or quantitative) or a subsequently positive Western blot (WB) or equivalent HIV-1 confirmatory assay (e.g. Geenius assay) if no positive HIV-1 RNA test was available.

A positive HIV Ab or HIV Ag/Ab Combination Assay or p24 antigen test and a negative or indeterminate HIV confirmatory/differentiating test with a detectable HIV-1 RNA (qualitative or quantitative).

A positive HIV Ab or HIV-1 RNA or p24 antigen and positive WB or Geenius HIV-1/HIV-2 Supplemental Assay that is negative for p31 band.

Disqualifiers

Breastfeeding or plans to become pregnant within the next 36 months.

Known allergy/sensitivity or any hypersensitivity to components of study treatment or its formulation.

Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.

Receipt of any investigational vaccine within 6 months prior to Step 1 entry.

Trial design

Design model

Sequential

Treatments tested in this trial

  • VRC07-523LS

    Biological/Vaccine

    Administered by Intravenous (IV) infusion at Week 0 and 12 weeks later

  • PGT121.414.LS

    Biological/Vaccine

    Administered by IV infusion at Week 0

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 2 interventions
Group B: Arm BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of participants experiencing a Grade ≥3 Adverse Event (AE) or Serious Adverse Events (SAE) that are related to VRC07-523LS or PGT121.414.LS

Time frame
Baseline through 36 weeks after the last dose of study treatment received
2

Proportion of study participants experiencing viral suppression, defined as HIV-1 RNA <200 copies/mL and remaining off ART

Time frame
At 62 weeks after Step 1 entry

Secondary outcomes

1

Change from Step 1 entry in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells

To be measured focusing on unspliced and single spliced env mRNA and corresponding total and env DNA.

Time frame
Study entry through 72 weeks
2

Change from Step 1 entry in low-level viremia measured by single copy assay (SCA)

Time frame
Study entry through 72 weeks
3

Change from Step 1 entry in levels of intact proviral DNA in CD4+ T-cells

Time frame
Study entry through 72 weeks
4

Change from Step 1 entry in levels of inducible infectious virus on CD4+ T-cells

Time frame
Study entry through 72 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Allergy and Infectious Diseases (NIAID)

Lead sponsor

Monogram Biosciences

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: