This study will evaluate the safety and virologic effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), alone or in combination with antiretroviral therapy (ART), in adults during early acute HIV infection.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Able and willing to complete the informed consent process
* Passes Test of Understanding
* 18 to 50 years of age
* Experiencing early acute HIV-1 infection as defined by blood samples on at least two separate days positive by nucleic acid testing within 21 days of a negative nucleic acid HIV-1 test OR by a positive nucleic acid test or a positive 4th generation enzyme immunoassay (EIA) in the context of a negative 2nd or negative 3rd generation HIV EIA test
* No history of antiretroviral therapy for any indication in the last 30 days.
* In general good health
* Willing to have blood samples collected and stored
* Able to participate for 25 weeks for study visits
* Willing to have photo or fingerprint taken for identification purposes
Female-Specific Criteria:
* Agrees not to become pregnant from the time of study enrollment until the last study visit. If a woman has no history of hysterectomy, tubal ligation or menopause, she must agree to use an effective birth control method: abstinence; male or female condoms; diaphragm or cervical cap with spermicide; intrauterine device; contraceptive hormones delivered by pills, patch, injections, or vaginally; and hormonal implants under the skin; or a male partner who has previously undergone a vasectomy.
* Negative beta-human chorionic gonadotropin (HCG) pregnancy test (urine or serum) on day of enrollment for any woman unless she is post-menopause for 24 consecutive months or has undergone a surgical procedu…
What they're measuring
1
Number of Participants With Grade 3 or Greater mAb-related Reactogenicity and mAb-related Adverse Events (AEs)
Timeframe: Measured through Week 24
2
Plasma Viral Load Change From Day 0 to Day 7
Timeframe: Measured through Day 7
Trial details
NCT IDNCT02591420
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)