HIV Infections Clinical Trial
To study the safety, toxicology, and activity of Peptide T (D-Ala-1-peptide-T-amide) in
humans and to find out more about the ability of peptide T to prevent, halt, and/or reverse
AIDS-associated immunologic disturbances.
Recent information suggests that the central nervous system (CNS) is often impaired in
HIV-infected individuals. The dysfunction of the CNS may be either a direct or an indirect
result of HIV infection. One method to prevent HIV infection is to block entry of the virus
into the cells of the body. Peptide T shows laboratory evidence of blocking the entrance of
HIV into cells that are susceptible to HIV infection. Studies that have been done indicate
that peptide T is nontoxic in the doses that are used in this study.
AIDS patients with minimal (group 1) or moderate (group 2) cognitive dysfunction (mental
impairment) receive an increasing schedule of three dosage levels of peptide T. All patients
receive an intravenous (IV) dose of peptide T for 10 days followed by the intermediate dose
and then the highest dose, each intravenously for 10 days. Following successful completion
of 3 IV doses, four patients participate in an intranasal pharmacokinetic (blood level
study) dosage trial of 3 doses (different from IV) of peptide T once for each of 3
successive days. Follow-up continues for up to 1 year.
n/a
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
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