HPTN 081 AMP Study
- Conditions
- HIV/AIDS
- Registration Number
- PACTR202005582198497
- Lead Sponsor
- Division of AIDS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Female
- Target Recruitment
- 82
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
8. Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling
9. Persons born Female (assigned female sex at birth) and identifying as female, who, in the 6 months prior to randomization, has had vaginal and/or anal intercourse with a male partner
Exclusion criteria
General
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
Vaccines
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
Clinically significant medical conditions
9. Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
? Any contraindication to repeated infusions or blood draws, including inability to establish venous access;
? A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer’s health or well-being during the study period; or
A condition or process for which signs or symptoms could be confused with reactions to VRC01.
10. Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or infusion reactions, or a volunteer’s ability to give informed consent
11. Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
12. Asthma, other than mild, well-controlled asthma
13. Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
14. Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator’s estimation, has a reasonable assurance of sustained cure. or who is unlikely to experience recurrence of malignancy during the period of the study)
15. Seizure disorder: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
16. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema
17. History of receiving transplantation of life-saving organs or tissue (includes heart, kidney, pancreas, lungs, liver, and intestines)
18. Known hepatic or renal dysfunction
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ocal and systemic reactogenicity signs and symptoms, laboratory measures of safety, AEs, SAEs, and rates of discontinuation;Documented HIV-1 infection by the Week 80 study visit
- Secondary Outcome Measures
Name Time Method Serum concentration of VRC01 in participants assigned to receive the mAb (ELISA, neutralizing assay);Serum mAb effector functions to HIV-1 Envs representing variability of the VRC01 antibody footprint;Sequences of breakthrough HIV infections from the earliest available HIV-positive plasma samples;VRC01 neutralization-sensitivity of, and effector function against, HIV strains from infected trial participants from the earliest available post–HIV-infection serum samples