Expanded Access: Programs that
Provide Patients with Access to New HIV
Medications
Expanded access programs
provide patients with limited treatment options a way to add
investigational medications to their treatment regimen. Through expanded
access, investigational medications are available to patients outside of
clinical trials if:
- the medication is used to
treat a serious or life-threatening disease that cannot be properly
managed with currently available therapies
- the medication is being
studied in clinical trials or all clinical trials have been
completed
- the medication being
studied in clinical trials shows adequate safety and efficacy data
The Food and Drug
Administration (FDA) reviews the clinical trial data to assure that the
medication is safe and effective before granting expanded access approval.
Learn more about expanded access
approval here.
Expanded access programs
allow HIV patients experiencing treatment
failure access to novel therapies before they are approved by the FDA.
Currently there are two anti-HIV medications available through expanded
access: MK-0158
and TMC125.
MK-0158 is a leading candidate in a new class of antiretroviral
medications called integrase
inhibitors. Inhibition of integrase
prevents insertion of HIV DNA into the human DNA genome, thus blocking the
ability of HIV to replicate. TMC125 is an investigational non-nucleoside
reverse transcriptase inhibitor (NNRTI). NNRTIs work by blocking
reverse transcriptase, a protein that HIV needs to make more copies of
itself.
Find Up-to-Date Clinical Trial
Information at AIDSinfo!
Looking for a comprehensive,
searchable listing of HIV/AIDS-related clinical trials? AIDSinfo
has you covered. Visit the Clinical Trials
section of our Web site to find trials by
clinical category (for example, trials for treatment-experienced or
HCV-coinfected patients), trial site location, age group, or particular
drug of interest. AIDSinfo also provides clinical trial information
in
Spanish.
HIV-negative? You can still
participate in a clinical trial of an HIV drug or vaccine! Simply check
the box next to “trials looking for HIV-negative volunteers” to find
trials that want to hear from YOU.
To learn more about clinical
research, check out our fact sheet “What
Is an HIV/AIDS Clinical Trial” (¿Qué es un ensayo clínico sobre el
SIDA?),
or call our health information specialists at
800-448-0459—they will be glad to answer your questions and help you find
trials.
