HIV Negative and HIV Prevention

AMP (HPTN 085)

To further test the idea of using VRCO1, a broadly neutralizing monoclonal antibody, to prevent HIV. This antibody neutralizes/kills as much as 91% of HIV in tested samples. The VRC01 antibody or placebo is given as an IV infusion ten times, once every eight weeks.  Participants interested in PrEP, can access Truvada through the study’s medication assistance program, but require an outside provider to manage PrEP long-term.
Population: MSM, transgender women, transgender men
Locations: Chapel Hill / Durham / Raleigh
Duration: 2 years

Contact: Kristen Hancock, RN at 919-966-3606

WEB: Fill out our contact form for this and other prevention studies

More Info: AMP Study

(same as above) HVTN 704/HPTN 085: A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection

 Give PrEP a Shot (HPTN 083)

Assessing the safety and efficacy of cabotegravir, an investigational, long-acting, injectable HIV medication, versus Truvada, the only FDA-approved medication for HIV prevention. Participants are randomized 1:1 to receive active cabotegravir or Truvada and an appropriate matching placebo. During the first step of the study, participants take oral cabotegravir or oral Truvada for five weeks; in the second step, participants continue oral Truvada (or placebo) and begin receiving gluteal injections of cabotegravir (or placebo) every eight weeks for up to 3.5 years. In step three, all participants receive open-label Truvada for one year to prevent HIV infection while residual cabotegravir levels slowly dissipate over time.
Population: MSM, transgender women (born male)
Location: Chapel Hill / Greensboro
Duration: Up to 4.5 years
Contact: Becky Straub, RN, 919-843-9975 or Miriam Chicurel-Bayard, RN, 919-843-9922
WEB: Fill out our contact form for this and other prevention studies

(same as above) HPTN 083: A phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumerate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis In HIV-Uninfected Cisgender Men and Transgender Women who have Sex with Men

DISCOVER

Evaluating the safety and efficacy of Descovy (emtricitabine/tenofovir alafenamide) compared to Truvada (emtricitabine/tenofovir disoproxil) once daily for the prevention of HIV. Participants are randomized to 1:1 to Truvada or Descovy.  They will take 2 tablets daily for approximately 2 years.  After enrollment, participants will attend a study visit 1 month after starting medicine and then are seen every 3 months for follow-up safety labs, assessments and medication refills.
Population: MSM, transgender women (born male)
Locations: Chapel Hill / Durham / Raleigh
Duration: 2 years
Contact: David Currin, RN, 919-966-2624
WEB: Fill out our contact form for this and other prevention studies

(same as above) GS-US-412-2055 - The Discover study: A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex with Men and Are At Risk of HIV-1 Infection

CID 0702: Apheresis procedures to obtain leukocytes from HIV negative subjects

Q:Samples used as a negative control for exploring new methods of activating resting HIV infected cells in laboratory
POP: must be HIV negative and > 18 years of age
DUR: up to 3 years
CALL: Caroline Baker, 919-966-2623

Vical: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 (HSV-2) Therapeutic DNA Vaccine in Adults with Symptomatic Genital HSV-2 Infection

Q:to evaluate the safety and efficacy of 4 doses of VCL-HB01, a therapeutic HSV plasmid DNA vaccine formulated with Vaxfectin® in HSV-2 adults with frequent recurrences
POP: Patients cannot have HIV, Hep B, or Hep C. Must be seropositive for herpes simplex-2 and otherwise a healthy male or female, 18 to 50 years of age with a minimum of a 1-year history of recurrent genital HSV-2. Once fully vaccinated, must be willing to return for clinical exams for every recurrent outbreak.
MED: VCL-HB01, a therapeutic HSV plasmid DNA vaccine. Subjects will be randomized 2:1 to receive either VCLHB01 or placebo via IM injection on Days 0, 28, 56, and 84.
DUR: 15 months (12 months follow-up after final vaccination)
CALL: Susan Blevins, ANP-C, 919-843-8763