CAPRISA 095 Study: Phase 1 study to assess the effect of broadly neutralizing monoclonal antibodiesCAP256V2LS and VRC07-523LS combined with antiretroviral therapy on the HIV-1 latent reservoir (NeutART)

Phase 1

• Conditions: HIV/AIDS

• Registration Number: PACTR202309578224660
• Lead Sponsor: Centre for the AIDS Programme of Research in South Africa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-21
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adults =18 years of age
• Able and willing to complete the informed consent process
CAPRISA 095 Protocol
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Version 1.0 06 May 2022
• HIV-positive, ART-naïve at screening with a VL > 1000, and due to initiate ART
• CD4 count of = 400 cells/µl
• Able and willing to participate in an ATI trial with a maximum interruption of 24 weeks after 12 months on ART
• Able to understand the information provided, including the potential impact and/or risks linked to study product administration, willing to comply with protocol procedures, and has access to the clinical research site for the study duration.
• Based on clinical assessment, participant must be in good general health with no major comorbidities or AIDS-defining illness, as per opinion of the Principal Investigator (PI) or designee.
• Haemoglobin = 10 g/dl.
• Platelets = 100,000 cells/mm3
• eGFR > 60 mL/min/1.73m2
• Alanine aminotransferase (ALT) < 2.5 times the institutional upper limit of normal.
• Negative pregnancy test for females.
• If female and of reproductive potential, has evidence of effective contraceptive use and is willing to adhere to effective contraceptive use during the study period.
• Willing to have blood samples collected, stored, and used for research purposes.

Exclusion Criteria

• Any clinically significant acute or chronic medical condition or other circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study or jeopardises the safety or rights of the participant.
• Positive Hepatitis B surface antigen (HBsAg) or positive HCV RNA (not exclusionary: positive HCV Ab with negative HCV RNA)
• For female participants, currently pregnant or breastfeeding, or planning a pregnancy during the study period.
• A history of alcohol or substance use judged by the PI to potentially interfere with participant study compliance.
• Prior participation in an investigational HIV vaccine trial or HIV mAb trial, except if proof of allocation to the placebo arm is available.
• Administration of a mAb or polyclonal immunoglobulin within 28 days prior to enrolment.
• Any history of anaphylaxis and related symptoms such as hives, respiratory difficulty, or angioedema.
• Evidence of autoimmune disease or currently receiving immunosuppressive therapy.
• Receipt of any vaccines within 14 days of enrolment.
• Participants in the study may not take part in other concurrent research studies that would interfere with the objectives of this study. The determination of whether participation in another study would be exclusionary for a given participant will be made by the PI/designee.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether monoclonal antibodiesCAP256V2LS and VRC07-523LS, combined with ART affects time to viral load rebound / ART reinitiation post treatment interruption formation of the HIV-1 latent reservoir

Secondary Outcome Measures

Name	Time	Method
To understand the mechanism of how CAP256V2LSand VRC07-523LS, combined with ART, affects the formation and size of the HIV-1 latent reservoir.