NEW STUDIES    ONGOING STUDIES

The Step Study (HVTN 502/Merck 023): A Phase II HIV Vaccine Study
This is a Phase II Proof of Concept study of an experimental vaccine that may one day prevent HIV infection or keep people who do become HIV infected healthier. Volunteers cannot become HIV infected or get AIDS by receiving this vaccine.

This study is to find out if a group intervention can lower sexual risk of gay and bi men who use alcohol or drugs. It’s open to men who are positive or negative for HIV.

UNITY
An intervention studying the efficacy of enhanced HIV counseling and HIV vaccine education with substance using women

Ongoing Studies
   Phase I Vaccine Trial (HVTN 050 / Merck 018)    Phase I Vaccine Trial (HVTN 052)
       

Phase I Vaccine Trial (HVTN 050 / Merck 018)
A Phase I trial is the first setting where an experimental HIV
vaccine is given to people. Such a trial usually enrolls about
20 to 100 HIV-negative volunteers. A Phase I trial primarily
seeks information on safety, looking for any vaccine-related
side effects. This is done by comparing the vaccine with a
control or placebo (an inactive substance, such as saline). A
Phase I trial can also provide data on the most effective dose
and administration schedule (the time between vaccinations)
that achieve the optimal immune responses. Scientists may also be able to analyze results to determine if the vaccine will
have an effect against different variations of HIV found
around the world. Phase I trials are randomized and double-blinded. Neither the participant nor the clinician knows who has received a vaccine or placebo. A Phase I trial typically lasts 12 to 18 months. Experimental vaccines used in all phases of testing are not produced from live virus or from HIV-infected human cells. Volunteers cannot get HIV infection or AIDS by receiving an experimental vaccine.

This study is now closed for enrollment

More information on Phase I Vaccine Trial
(HVTN 050) is available at:

http://chi.ucsf.edu/vaccines/vaccines?page=vc-01-02

Phase I Vaccine Trial (HVTN 052)
A Phase I trial is the first setting where an experimental HIV vaccine is given to people. Such a trial usually enrolls about
20 to 100 HIV-negative volunteers. A Phase I trial primarily seeks information on safety, looking for any vaccine-related
side effects. This is done by comparing the vaccine with a
control or placebo (an inactive substance, such as saline). A
Phase I trial can also provide data on the most effective dose
and administration schedule (the time between vaccinations)
that achieve the optimal immune responses. Scientists may also be able to analyze results to determine if the vaccine will
have an effect against different variations of HIV found
around the world. Phase I trials are randomized and double-blinded. Neither the participant nor the clinician knows who has received a vaccine or placebo. A Phase I trial typically lasts 12 to 18 months. Experimental vaccines used in all phases of testing are not produced from live virus or from HIV-infected human cells. Volunteers cannot get HIV infection or AIDS by receiving an experimental vaccine.

This study is now closed for enrollment.
More information on Phase I Vaccine Trial
(HVTN 052) is available at:

http://www.hvtn.org/pdf/trials/prot052_QA8Mar04.pdf