Safety and Therapeutic Efficacy of the VRC01 Antibody in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection
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|ClinicalTrials.gov Identifier: NCT02664415|
Recruitment Status : Completed
First Posted : January 27, 2016
Last Update Posted : October 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Biological: VRC01 Biological: Placebo for VRC01||Phase 2|
Human monoclonal antibodies (mAbs) may have the potential to treat HIV infection by preventing the spread of the virus. This study will evaluate an experimental mAb known as VRC-HIVMAB060-00-AB (VRC01). The purpose of this study is to evaluate the safety and therapeutic efficacy of VRC01, when administered during analytic treatment interruption (ATI), in adults who began antiretroviral therapy (ART) during early acute HIV infection.
The study will enroll participants from the RV 254 study who were diagnosed during early acute HIV infection and who have been on ART. At study entry, participants will stop taking their antiretroviral (ARV) medications. They will be randomly assigned to receive an intravenous (IV) infusion of VRC01 or placebo at Weeks 0 (study entry), 3, 6, 9, 12, 15, 18, 21, and 24. For 7 days following each infusion, participants will be asked to record and report any symptoms to study researchers.
In addition to the infusion visits, participants will attend follow-up visits for 48 weeks. Study visits may include physical examinations, blood collection, and urine collection. Neurocognitive testing will take place at select study visits. Some participants may take part in optional study procedures including mucosal secretion collection, MRI brain scan, colon biopsy, lymph node biopsy, leukapheresis, and lumbar puncture.
Study staff will monitor participants' HIV throughout the study, and participants will end their participation in the study and restart their ARV medications, if needed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Safety and Therapeutic Efficacy of the Broadly Neutralizing HIV-1 Specific Monoclonal Antibody VRC01 During Analytic Treatment Interruption in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection|
|Study Start Date :||August 2016|
|Actual Primary Completion Date :||August 4, 2017|
|Actual Study Completion Date :||August 4, 2017|
Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.
40 mg/kg; administered IV
Other Name: VRC-HIVMAB060-00-AB
Placebo Comparator: Placebo for VRC01
Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.
Biological: Placebo for VRC01
Sodium Chloride for Injection 0.9%, USP; administered IV
- Incidence of serious adverse event at any time up to 10 weeks after the last infusion of VRC01 or placebo [ Time Frame: Measured through Week 34 ]
- Number of participants with sustained virologic suppression, without indication for ART resumption [ Time Frame: Measured through Week 24 ]sustained virologic control (HIV RNA <50 copies/mL)
- Time to viral rebound after cessation of ART [ Time Frame: Measured through Week 48 ]
- Level of rebound viremia after cessation of ART [ Time Frame: Measured through Week 48 ]
- Time to ART resumption for any reason after cessation of ART [ Time Frame: Measured through Week 48 ]
- Detectable HIV RNA via single copy assay [ Time Frame: Measured through Week 48 ]
- CD4+ T cell count [ Time Frame: Measured through Week 48 ]
- Cell-associated HIV RNA and DNA in the peripheral compartment [ Time Frame: Measured through Week 48 ]
- Neuropsychological battery performance [ Time Frame: Measured through Week 48 ]
- Score on the Control and Attention task (i.e., Flanker Task) (computerized test of cognition) [ Time Frame: Measured through Week 48 ]
- Frequency of hospitalization [ Time Frame: Measured through Week 48 ]
- Incidence of non-AIDS related conditions [ Time Frame: Measured through Week 48 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664415
|SEARCH Thai Red Cross AIDS Research Centre Non-Network CRS|
|Bangkok, Thailand, 10330|
|Study Chair:||Jintanat Ananworanich, MD, PhD||US Military HIV Research Program|