Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Primary: To determine the clinical effect of zidovudine (AZT) compared to placebo in terms of
time to progression to AIDS (i.e., occurrence of major opportunistic infections, dementia,
and malignancies) or death. Initial drug assignment will be changed to open-label AZT for
patients who experience a sustained decline in CD4 lymphocyte concentration to less than 200
cells/mm3, but analysis will be based on initial treatment assignment. To determine the
immunologic effect of AZT compared to placebo in terms of time to drop in CD4 lymphocyte
concentration of at least 25 percent from baseline assessment. To determine the antiviral
effect of AZT compared to placebo in eradicating or suppressing HIV. Secondary: To determine
the effect of AZT compared to placebo on the immune status of HIV-infected patients by
comparing lymphocyte profiles and indices. To determine the long-term toxicities of AZT
compared to placebo in terms of abnormalities in BL, hepatic function, renal function, skin,
gastrointestinal system, and central nervous system. To describe the natural history of AIDS
related complex (ARC) in placebo patients in terms of initial CD4 lymphocyte concentration
and the Walter Reed staging system.