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

NCT ID: NCT00000392

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1990-01-31
• Study Completion Date: 1996-08-31

Brief 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.

Conditions

HIV Infections; Cognition Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Peptide T

Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months

Group Type: ACTIVE_COMPARATOR

Peptide T

Intervention Type: DRUG

Placebo

Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Peptide T

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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).

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

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:

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Los Angeles County - USC Med Ctr

Los Angeles, California, United States

UCSD

San Diego, California, United States

Univ of Miami School of Medicine

Miami, Florida, United States

Countries

United States

References

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. doi: 10.1001/archneur.55.1.41.

Reference Type: BACKGROUND

PMID: 9443710 (View on PubMed)

Other Identifiers

N01 MH00013

Identifier Type: -

Identifier Source: org_study_id