A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients.

Inclusion Criteria: Patients must have: HIV infection. Ability to give informed consent. Ability to participate in an outpatient study. Allowed: Short course antimicrobials. Not breast-feeding Abstinence or agree to use barrier methods of birth control / contraception during the study 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 Exclusion Criteria: Excluded: Asymptomatic HIV seropositive or lymphadenopathy syndrome diagnoses only (CDC criteria). 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. Breast-feeding Positive pregnancy test Pregnant No abstinence or no agreement to use barrier methods of birth control / contraception during the study