HIV Infections Clinical Trial
Official title:
Immunologic Effect After Single Dose Atvogen in Healthy Volunteers and Asymptomatic HIV-Infected Patients
To evaluate the degree and sequence of immunologic enhancement and the cellular resistance
to certain infections after a single dose of atvogen (ampligen). In addition, the
relationship between activation of immune cells and biochemical markers of that activation
will be studied.
Treatment of patients with HIV infection must address both the primary viral infection and
the subsequent immune deficiency, which is the primary cause of mortality in AIDS. In vitro
studies of ampligen have shown it will inhibit HIV infection. Ampligen may also minimize the
toxicity of many drugs used in the treatment of AIDS and induce an antiviral state in the
brain that may be useful in treating neurologic symptoms of HIV infection. The time course
and degree of immunologic response to ampligen remain unknown although they are essential
for proper use of the drug in the treatment of HIV infection and perhaps other clinical
problems.
Treatment of patients with HIV infection must address both the primary viral infection and
the subsequent immune deficiency, which is the primary cause of mortality in AIDS. In vitro
studies of ampligen have shown it will inhibit HIV infection. Ampligen may also minimize the
toxicity of many drugs used in the treatment of AIDS and induce an antiviral state in the
brain that may be useful in treating neurologic symptoms of HIV infection. The time course
and degree of immunologic response to ampligen remain unknown although they are essential
for proper use of the drug in the treatment of HIV infection and perhaps other clinical
problems.
Ten healthy volunteers and 10 HIV-infected patients are randomized between ampligen or
placebo group. Five volunteers in each group receive a single dose of ampligen on day 1 and
a single dose of placebo on day 8. The other 5 volunteers receive the drug and placebo on
day 8 and 1, respectively. Seven days of observation and testing follow each administration
of drug or placebo and also allow the body to eliminate the drug.
;
Masking: Double-Blind, Primary Purpose: Treatment
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