Clinical Trials Logo
  1. Home
  2. Acute HIV Infection
  3. NCT05719441

A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission

Acute HIV Infection Clinical Trial

Official title:
A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission

Clinical Trial Summary

A5388 is a phase II, two-arm, randomized, double-blind, placebo-controlled study that will enroll 48 antiretroviral therapy (ART)-naïve adults with acute HIV infection (AHI) in order to determine whether: - Administration of combination HIV-specific broadly neutralizing antibody (bNAb) therapy in addition to ART during acute HIV infection (AHI) will be safe. - Participants who receive combination bNAb therapy in addition to ART during AHI will be more likely to demonstrate a delay in time to HIV-1 RNA ≥1,000 copies/mL for 4 consecutive weeks compared to participants who receive placebo plus ART. - Participants who receive combination bNAb therapy in addition to ART during AHI will demonstrate lower viral reservoirs and enhanced HIV-specific immunity compared to participants who receive placebo plus ART.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05719441
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Not yet recruiting
Phase Phase 2
Start date June 15, 2024
Completion date September 6, 2028
View Details
See also
  Status Clinical Trial Phase
Completed NCT02384395 - Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection N/A
Completed NCT00734344 - Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection N/A
Completed NCT01434706 - Implementation of Nucleic Acid Amplification Testing Screening to Identify Acute and Early HIV Infection N/A
Active, not recruiting NCT03711253 - Empiric Treatment for Acute HIV in the ED Phase 4
Completed NCT01154673 - Intense Acute Infection Study Phase 2/Phase 3
Terminated NCT00855413 - HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine Phase 4
Completed NCT02467439 - Acute Partner and Social Contact Referral: iKnow N/A
Completed NCT03579381 - Specimen Repository for HIV Immunopathogenesis
Completed NCT01369056 - HAART Adherence Among HIV-infected Persons and the Factors Affecting Treatment Adherence N/A
Completed NCT02170246 - Analysis of Telmisartan Administered With Antiretroviral Therapy (ART) in Patients With Acute HIV Infection Phase 1
Completed NCT02750059 - Using Telmisartan With ART During Acute HIV Infection to Reduce the CNS Reservoirs of HIV and Lymph Node Fibrosis Phase 2
Completed NCT02470351 - Assessment of the HIV CNS Reservoir, Neurological and Neuro-cognitive Effects, and Source of Rebound HIV in CNS N/A
Completed NCT02475915 - Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection Phase 1/Phase 2
Completed NCT00924898 - Treatment of Acute HIV With Emtricitabine, Tenofovir and Efavirenz (CID 0805) Phase 4
Completed NCT02614950 - Viral Suppression After Analytic Treatment Interruption in Thai Patients Who Initiated Highly Active Antiretroviral Therapy During Acute HIV Infection N/A
Completed NCT01197027 - Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals With Acute and Early HIV-Infection Phase 3
Active, not recruiting NCT02231281 - Early cART and cART in Combination With Autologous HIV-1 Specific Cytotoxic T Lymphocyte (CTL) Infusion in The Treatment of Acute HIV-1 Infected Adults Phase 3
Recruiting NCT05728996 - Netherlands Cohort Study on Acute HIV Infection
Recruiting NCT00796146 - Establish and Characterize an Acute HIV Infection Cohort in a High Risk Population
Recruiting NCT00796263 - Antiretroviral Therapy for Acute and Chronic HIV Infection Phase 3