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VRC 603: A Phase I Dose-Escalation Study of the Safety of AAV8-VRC07 (VRC-HIVAAV070-00-GT) Recombinant AAV Vector Expressing VRC07 HIV-1 Neutralizing Antibody in Antiretroviral -Treated, HIV-1 Infected Adults With Controlled Viremia

VRC 603: A Phase I Dose-Escalation Study of the Safety of AAV8-VRC07 (VRC-HIVAAV070-00-GT) Recombinant AAV Vector Expressing VRC07 HIV-1 Neutralizing Antibody in Antiretroviral -Treated, HIV-1 Infected Adults With Controlled Viremia


Phase 1

DESCRIPTION:

Doctors at the National Institutes of Health are recruiting participants for a study of the impact of a gene therapy on HIV-1 in infected adults. The therapy, an engineered virus designed only to impart a gene coding an antibody that can target HIV, will be delivered in one intramuscular (into the muscle) injection. Follow up will require weekly visits sloping down to monthly visits and, after the first year, twice a year visits for up to the 5-year point.


PATIENT MUST:

  • Be 18 to 60 years of age
  • Diagnosis of HIV-1 and on a stable antiretroviral regimen for greater than or equal to 3 months
  • Meet additional lab screening requirements for immune and organ health

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Study product will be injected one or more times in the upper arm or thigh using a needle. Participants weight will be measured to calculate the dose.
  3. For 7 days after getting the study product, participants will check their temperature with a thermometer. They will note any symptoms in an electronic or paper diary.
  4. Participants will have study visits. At each one, they will have a physical exam and medical history. They will have blood drawn and may have saliva collected.

The visit schedule:

  • For 12 weeks: 1 visit a week
  • For the next 12 weeks: 1 visit every other week
  • Then about 1 visit a month
  • After 1 year in the study: a visit every 6 months for the next 4 years.
  • Total study participation is 5 years.

LOCATIONS AND CONTACTS:

The study site is at the National Institutes of Health Clinical Center in Bethesda, Maryland. Map.

Primary contact: Laura Novik, R.N.  |  (301) 451-8715  |  [email protected]

 

SPONSOR INFORMATION:

The National Institute of Allergy and Infectious Diseases (NIAID)

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03374202

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