Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.

HIV Infections Clinical Trial

Official title:

Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000392
• Other study ID #: N01 MH00013
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2000
• Last updated: February 27, 2017
• Start date: January 1990
• Est. completion date: August 1996

Study information

• Verified date: October 2013
• Source: National Institute of Mental Health (NIMH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the chemical efficacy and safety of intranasally administered peptide T on neurocognitive function in HIV seropositive individuals.

Previous studies have shown that treatment with peptide T can result in cognitive improvement in HIV-infected patients.

Patients are randomized to receive either peptide T or placebo for the first 6 months. All patients then receive open-label peptide T for approximately 6 additional months. Neuropsychologic tests are used to determine drug effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: August 1996
• Est. primary completion date: August 1996
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients must have:

1. Cognitive dysfunction on neuropsychological testing.

2. HIV antibody positivity.

3. Expected survival of 6 months.

4. EITHER no use of an antiretroviral within the past 4 weeks OR use of approved regimens of AZT, ddI, or ddC.

5. Medically stable EKG and urinalysis.

6. Given informed, written consent to participate.

• Allowed:

1. Inhaled aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis, dapsone, cotrimoxazole, topical antifungal agents, nystatin or ketoconazole, acyclovir.

2. Amitriptyline (up to 50 mg/day) or an equivalent dose of another antidepressant for relief of peripheral neuropathy that is expected to remain unchanged throughout the first 6 months of the study.

• Abstinence or agree to use barrier methods of birth control / contraception during the study

• Negative pregnancy test within 30 days of study entry

• Bilirubin <= 3

• CD4 (Must be <= 500 cells/mm3 if patient is without non-cognitive HIV-related symptoms. CD4 count > 500 cells/mm3 allowed if patient has other (non-cognitive) HIV-related symptoms. ( 0 - 100 - 200 - 300 - 400 - 500 - 600 - 700 - 800 plus.)

• Creatinine <= 1.5 mg/dl

• Granulocytes >= 750

• Hemoglobin > 8 g/dl (No more than two transfusions per month permitted.)

• Other Lab Values Prothrombin time > 70 percent of control.

• Platelet Count >= 75000 /mm3

• SGOT(AST) < 5 x ULN (ULN = upper limit of normal).

Exclusion Criteria:

• Patients with the following are excluded:

1. History of mental retardation or learning disability.

2. Evidence of current DSM-III-R Axis I disorder within 3 months prior to study entry or past history of psychotic disorder or bipolar mania.

3. History of neurologic disorder not secondary to HIV infection (e.g., head trauma requiring medical observation or hospitalization, seizure disorder).

• Patients with the following symptoms or conditions are excluded:

1. Kaposi's sarcoma or other malignancy likely to require chemotherapy during the first 6 months of the study.

2. Serious underlying medical problems that may complicate interpretation of the treatment results, including unstable diabetes mellitus, severe arteriosclerotic heart disease, uncontrolled hypertension, or hepatic or renal failure.

3. Non-HIV related condition that is likely to interfere with interpretation of neuropsychologic test results.

4. Inability to participate in neuropsychologic testing or unable to comply with intranasal study medication administration.

• Excluded within 4 weeks prior to study entry:

1. Antiretrovirals except as allowed in the Patient Inclusion Criteria.

2. Psychoactive agents (e.g., benzodiazepines, antidepressants, antipsychotics, amphetamines)

Excluded within 8 weeks prior to study entry:

Long-acting psychoactive agents (e.g., Prozac).

• Active alcohol abuse in the past 3 months, or abuse judged by the investigators as likely to interfere with the analyses of neuropsychologic function. Abuse of cocaine, marijuana, heroin or other opiates (including methadone), barbiturates, amphetamines or other substances within the past 3 months, judged by the investigators as likely to interfere with the analyses of neuropsychologic tests.

• Positive pregnancy test within 30 days of study entry

• No abstinence or no agreement to use barrier methods of birth control / contraception during the study

Related Conditions & MeSH terms

• Cognition Disorders
• HIV Infections

Intervention

Drug:
• Peptide T

• Placebo

Locations

Country	Name	City	State
United States	Los Angeles County - USC Med Ctr	Los Angeles	California
United States	Univ of Miami School of Medicine	Miami	Florida
United States	UCSD	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Heseltine PN, Goodkin K, Atkinson JH, Vitiello B, Rochon J, Heaton RK, Eaton EM, Wilkie FL, Sobel E, Brown SJ, Feaster D, Schneider L, Goldschmidts WL, Stover ES. Randomized double-blind placebo-controlled trial of peptide T for HIV-associated cognitive impairment. Arch Neurol. 1998 Jan;55(1):41-51. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Global Neurocognitive Performance z Score From Baseline	Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)	Baseline and 6 months
Secondary	Change in Neurocognitive Performance Domain z Scores From Baseline	Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)	Baseline and 6 months