Clinical trial NCT00000393: A Phase I Trial of Peptide T: Efficacy for the Neuropsychiatric Complications of Acquired Immunodeficiency Syndrome (AIDS).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Cognition Disorders
Keywords: Acquired Immunodeficiency Syndrome
Lead sponsor: National Institute of Mental Health (NIMH)
Sponsor class: NIH
First posted: 2000-01-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* History of either opportunistic infection and/or Kaposi's sarcoma, and/or serologic evidence of past infection with HIV. Ability to give informed consent.
* Allowed but discouraged: Antiretroviral medication. Immunomodulating medication. Psychoactive medication.
* Not breast-feeding
* Abstinence or agree to use barrier methods of birth control / contraception during the study
* Not pregnant
* Negative pregnancy test
* CD4 \>= 200 cells/mm3 (200 - 300 - 400 - 500 - 600 - 700 - 800 plus).
* Creatinine \<= 1.6 mg/dl
* Hemoglobin \>= 12 g/dl
* Platelet Count \>= 100000 /mm3

Exclusion Criteria:

* Patients with the following diseases or symptoms are excluded: Space-occupying lesion in brain. Life-threatening opportunistic infection at time of entry into trial. History of major psychiatric illness prior to 1977 or time of initial exposure to HIV, if that is known.
* Patients with the following diseases or symptoms are excluded: Space-occupying lesion in brain. Life-threatening opportunistic infection at time of entry into trial. History of major psychiatric illness prior to 1977 or time of initial exposure to HIV, if that is known.
* Excluded within 4 weeks of study entry:

Antiretroviral agents. Anticancer treatments. Psychoactive agents.

Excluded within 4 months of study entry:

Suramin.

* Avoid: Antiretroviral medication. Immunomodulating medication. Psychoactive medication.
* Excluded within 4 weeks of study entry:

Radiation.

* Breast-feeding
* Positive pregnancy test
* Pregnant
* No abstinence or no agreement to use barrier methods of birth control / contraception during the study

Primary outcomes:
measure: Patients performance on neuropsychological tests
timeFrame: 10 days plus 10 days plus 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County - USC Med Ctr
state: California
Study officials:
affiliation: National Institute of Mental Health (NIMH)
name: Bridge TP
role: STUDY_CHAIR
References: