HIV
and AIDS
Human Immunodeficiency Virus and
Acquired Immunodeficiency Syndrome
HIV/AIDS Treatment INDs Allowed to Proceed
The Treatment IND (Investigational New Drug) mechanism was established by
FDA to allow patients suffering from serious or life-threatening conditions
for which there are no satisfactory treatments to obtain promising experimental
drugs that have undergone sufficient clinical testing to show they may be safe
and effective.
Eleven treatment INDs for promising AIDS-related products have been allowed
to proceed since the Treatment IND regulations became effective in June 1987.
New Drug Applications or Product License Applications have now been approved
for all of the eleven products previously available through treatment INDs.
- Trimetrexate glucuronate (February
1988), for the treatment of Pneumocystis carinii pneumonia in AIDS patients
who cannot tolerate standard forms of treatment.
- Ganciclovir (November 1988) for the treatment of cytomegalovirus retinitis
in AIDS patients.
- Aerosolized pentamidine (February 1989) for the prevention of Pneumocystis
carinii pneumonia in AIDS patients.
- Erythropoietin (June 1989) for the treatment of zidovudine-related anemia.
- Didanosine (ddI) (September 1989) for the treatment of patients with AIDS
or AIDS-Related Complex who are intolerant to zidovudine (AZT).
- Zidovudine (AZT) (October 1989) for the treatment of pediatric patients
with HIV disease.
- Zalcitabine (ddC) (May
1991) for the treatment of patients with AIDS or advanced AIDS Related Complex
who cannot be maintained on zidovudine (AZT).
- Atovaquone (November 1991) for the treatment of AIDS patients with Pneumocystis
carinii pneumonia who are intolerant or unresponsive to trimethoprim-sulfamethoxazole.
- Rifabutin (March
1992) for prophylaxis against Mycobacterium avium complex bacteremia in AIDS
patients.
- Vistide (September
1995), intravenous cidofovir for HIV-infected persons with relapsing cytomegalovirus
(CMV) retinitis that has progressed despite treatment (Hoffmann-La Roche).
- Serostim (December 1994), a mammalian
derived recombinat human growth hormone for the treatment of AIDS-related
wasting (Serono Laboratories)
HIV/AIDS
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