Top
HIV-1 With Controlled Viremia - Healing Genes
1354
post-template-default,single,single-post,postid-1354,single-format-standard,mkdf-bmi-calculator-1.0,mkd-core-1.1.1,tribe-no-js,wellspring-ver-1.8,mkdf-smooth-page-transitions,mkdf-ajax,mkdf-grid-1300,mkdf-blog-installed,mkdf-header-standard,mkdf-no-behavior,mkdf-default-mobile-header,mkdf-sticky-up-mobile-header,mkdf-dropdown-slide-from-bottom,mkdf-full-width-wide-menu,mkdf-search-dropdown,elementor-default,elementor-template-full-width,elementor-kit-3486,elementor-page-2540

HIV-1 With Controlled Viremia

Share This Post

Share on facebook
Share on linkedin
Share on twitter
Share on email

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:

Researchers at the National Institutes of Health in Bethesda, MD, seek patients with human immunodeficiency virus to trial an experimental drug. The drug, a gene therapy delivered by a virus shell, should tell the patient’s cells to make an antibody called VRC07. This antibody attacks human immunodeficiency virus.

Study participants will receive intramuscular injections once or more, then are required to record their temperature daily. Follow up will be required weekly for 3 months, alternating weeks for 3 more months, and progressively fewer visits for a total of 5 years.


PATIENT MUST:

  • Be 18 to 60 years of age
  • Not be pregnant or breastfeeding, and willing to use contraception (either gender)
  • Be HIV-1-positive, confirmed through specific lab tests
  • Meet lab assessment requirements for overall health status
  • Be willing to maintain or establish a relationship with a primary health care provider for medical management of HIV infection while participating in the study

THE STUDY INVOLVES:

  1. Screening to confirm acceptance to the study.
  2. Intramuscular injections once or more.
  3. For 7 days, participants record their temperature daily.
  4. Follow up will be required weekly for 3 months, alternating weeks for 3 more months, reducing to 1 visit a month for the duration of the first year.
  5. After the first year, visits are required 2x a year for 4 years.

LOCATIONS & CONTACTS:
The study site is at the National Institutes of Health Clinical Center. Map.
 
Contacts
Laura Novik, R.N.  |  (301) 451-8715  |  [email protected]
 
SPONSORS
National Institute of Allergy and Infectious Diseases (NIAID)
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT03374202

Subscribe To Our Newsletter

Get updates and learn from the best

More To Explore

Vanquishing the Virus: 160+ COVID-19 Drug and Vaccine Candidates in Development

While President Trump continues to promote antimalarial drugs such as hydroxychloroquine sulfate and azithromycin to treat COVID-19—“What do you have to lose?” he exclaimed during the April 4 Coronavirus Task Force Briefing—the global community of drug discovery researchers and biopharmas is developing a much broader