To study the safety and toxicity of intranasal peptide T (D-Ala-1-peptide-T-amide) in
humans, and to find out how quickly and how much of a given dose enters the bloodstream and
how quickly it leaves the bloodstream. To obtain information on the ability of intranasal
peptide T to prevent, halt, and/or reverse the effects of AIDS on the central nervous
Studies have shown that AIDS is caused by a retrovirus. This virus works by inactivating or
destroying human CD4 cells (which are part of the human immune system). This in turn leads
to the observed immunologic defects and related illnesses, including HIV encephalopathy
(disease of the brain). One method of preventing AIDS is to prevent HIV from entering the
cell. HIV binds to the receptor CD4 site. Peptide T also binds to this site, and thus by
competing for that site, can block the binding of the virus to its receptor. Preliminary
animal and human studies indicate that peptide T is safe at the doses selected for this
Thirty patients with AIDS or AIDS related complex (ARC) are entered into the study to
receive an increasing schedule of three dosage levels of intranasal peptide T for 12 - 16
weeks followed by a 1-month off-drug follow-up period and a subsequent 1-month return to the
drug. All patients receive an initial intravenous test dose of peptide T. The test dose is
administered over 1 hour, followed by an observation period of 8 hours in the outpatient
- Patients must have:
HIV infection. Ability to give informed consent. Ability to participate in an outpatient
- Allowed: Short course antimicrobials.
- Not breast-feeding
- Abstinence or agree to use barrier methods of birth control / contraception during
- Not pregnant
- Negative pregnancy test
- CD4 100 to 500 cells/mm3 (100 - 200 - 300 - 400 - 500).
- Creatinine > 1.6 mg/dl
- Hemoglobin >= 12 g/dl
- Platelet Count >= 100000 /mm3
- Excluded: Asymptomatic HIV seropositive or lymphadenopathy syndrome diagnoses only
- Patients with the following conditions are excluded: Evidence of life-threatening
opportunistic infection at time of entry into trial. Clinical evidence of active
central nervous system disease secondary to immune dysregulation associated with HIV
infection. Previous history of major psychiatric illness prior to 1977 or the time of
initial exposure to HIV, if that is known. Evidence of clinically significant major
psychiatric disturbance other than depression.
- Excluded within 4 weeks of study entry: Suramin. Antiretroviral agents. Anticancer
treatments. Psychoactive agents.
- Excluded: Antivirals or immunomodulators.
- Excluded within 4 weeks of study entry: Radiation.
- Evidence of active substance abuse during 30 days prior to entry into trial. All
behavior that can put patient at risk for reinfection with HIV: sexual contact with
others known to have HIV infection, unsafe sexual practices, or sharing of needles or
other intravenous equipment.
- Positive pregnancy test
- No abstinence or no agreement to use barrier methods of birth control / contraception
during the study