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Clinical Trials/PACTR202005582198497
PACTR202005582198497
Other
Phase 2

A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection in women in sub-Saharan Africa. DAIDS DOCUMENT ID 12045

Division of AIDS0 sites82 target enrollmentMay 2, 2020
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ConditionsHIV/AIDS

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
Division of AIDS
Enrollment
82
Status
Other
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 2, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Division of AIDS

Eligibility Criteria

Inclusion Criteria

  • •Inclusion criteria
  • •General and Demographic Criteria
  • •1\. Age of 18 to 40 years
  • •2\. Access to a participating CRS and willingness to be followed for the planned duration of the study
  • •3\. Ability and willingness to provide informed consent
  • •4\. Assessment of understanding: volunteer demonstrates understanding of this study and completes a questionnaire prior to first infusion with verbal demonstration of understanding of all questionnaire items answered incorrectly
  • •5\. Agrees not to enroll in another study of an investigational research agent for the duration of the participant’s trial participation
  • •6\. Good general health as shown by medical history, physical exam, and screening laboratory tests
  • •HIV\-Related Criteria:
  • •7\. Willingness to receive HIV test results

Exclusion Criteria

  • •Exclusion criteria
  • •1\. Investigational research agents received within 30 days before first infusion
  • •2\. Body mass index (BMI) \= 40
  • •3\. Pregnant or breastfeeding
  • •4\. Any reactive, indeterminate, or positive HIV test, even if subsequent testing indicates that the individual is not HIV infected, except as permitted by the HVTN 703/HPTN 081 PSRT
  • •5\. HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 703/HPTN 081 PSRT will determine eligibility on a case\-by\-case basis.
  • •Immune System
  • •6\. Serious adverse reactions to VRC01 formulation components such as sodium citrate, sodium chloride, and L\-arginine hydrochloride, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain.
  • •7\. Autoimmune disease, including Type I diabetes mellitus (Not excluded from participation: Volunteer with mild, stable and uncomplicated autoimmune disease that does not require consistent immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate reactogenicity and AE assessments)
  • •8\. Immunodeficiency syndrome

Outcomes

Primary Outcomes

Not specified

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