Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT00000392
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2000-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D000386', 'term': 'AIDS-Related Complex'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015717', 'term': 'Peptide T'}], 'ancestors': [{'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bvitiell@mail.nih.gov', 'phone': '301-443-3357', 'title': 'Benedetto Vitiello, MD - Supervisory Medical Officer', 'organization': 'NIMH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Only data for the events that were statistically significant between the two treatment groups could be retrieved because adverse event data are lost.', 'eventGroups': [{'id': 'EG000', 'title': 'Peptide T', 'description': 'Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months\n\nPeptide T', 'otherNumAtRisk': 106, 'otherNumAffected': 75, 'seriousNumAtRisk': 106, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months\n\nPlacebo', 'otherNumAtRisk': 109, 'otherNumAffected': 57, 'seriousNumAtRisk': 109, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Depression or Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 42}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Immune system disorders'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Global Neurocognitive Performance z Score From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peptide T', 'description': 'Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months\n\nPeptide T'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.24', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)', 'unitOfMeasure': 'z score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Neurocognitive Performance Domain z Scores From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peptide T', 'description': 'Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months\n\nPeptide T'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months\n\nPlacebo'}], 'classes': [{'title': 'Verbal fluency', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Visuospatial ability', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Abstract thinking', 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Speed of information processing', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Working memory', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Learning and retention', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Motor performance', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)', 'unitOfMeasure': 'z score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Peptide T', 'description': 'Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months\n\nPeptide T'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'provided complete NP outcome data constituted the sample for the primary efficacy analyses', 'groupId': 'FG000', 'numSubjects': '66'}, {'comment': 'provided complete NP outcome data constituted the sample for the primary efficacy analyses', 'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '32'}]}]}], 'preAssignmentDetails': 'Of 457 persons screened for cognitive impairment, 205 men and 10 women were randomized (106 to peptide T and 109 to placebo).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Peptide T', 'description': 'Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months\n\nPeptide T'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-39 years', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Information is not available for all participants.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Information is not available for all participants.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1990-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '1996-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-27', 'studyFirstSubmitDate': '2000-01-17', 'resultsFirstSubmitDate': '2015-07-17', 'studyFirstSubmitQcDate': '2000-01-17', 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-07-29', 'studyFirstPostDateStruct': {'date': '2000-01-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1996-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Global Neurocognitive Performance z Score From Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)'}], 'secondaryOutcomes': [{'measure': 'Change in Neurocognitive Performance Domain z Scores From Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)'}]}, 'conditionsModule': {'keywords': ['Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex'], 'conditions': ['HIV Infections', 'Cognition Disorders']}, 'referencesModule': {'references': [{'pmid': '9443710', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the chemical efficacy and safety of intranasally administered peptide T on neurocognitive function in HIV seropositive individuals.\n\nPrevious studies have shown that treatment with peptide T can result in cognitive improvement in HIV-infected patients.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must have:\n\n 1. Cognitive dysfunction on neuropsychological testing.\n 2. HIV antibody positivity.\n 3. Expected survival of 6 months.\n 4. EITHER no use of an antiretroviral within the past 4 weeks OR use of approved regimens of AZT, ddI, or ddC.\n 5. Medically stable EKG and urinalysis.\n 6. Given informed, written consent to participate.\n* Allowed:\n\n 1. Inhaled aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis, dapsone, cotrimoxazole, topical antifungal agents, nystatin or ketoconazole, acyclovir.\n 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.\n* Abstinence or agree to use barrier methods of birth control / contraception during the study\n* Negative pregnancy test within 30 days of study entry\n* Bilirubin \\<= 3\n* 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.)\n* Creatinine \\<= 1.5 mg/dl\n* Granulocytes \\>= 750\n* Hemoglobin \\> 8 g/dl (No more than two transfusions per month permitted.)\n* Other Lab Values Prothrombin time \\> 70 percent of control.\n* Platelet Count \\>= 75000 /mm3\n* SGOT(AST) \\< 5 x ULN (ULN = upper limit of normal).\n\nExclusion Criteria:\n\n* Patients with the following are excluded:\n\n 1. History of mental retardation or learning disability.\n 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.\n 3. History of neurologic disorder not secondary to HIV infection (e.g., head trauma requiring medical observation or hospitalization, seizure disorder).\n* Patients with the following symptoms or conditions are excluded:\n\n 1. Kaposi's sarcoma or other malignancy likely to require chemotherapy during the first 6 months of the study.\n 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.\n 3. Non-HIV related condition that is likely to interfere with interpretation of neuropsychologic test results.\n 4. Inability to participate in neuropsychologic testing or unable to comply with intranasal study medication administration.\n* Excluded within 4 weeks prior to study entry:\n\n 1. Antiretrovirals except as allowed in the Patient Inclusion Criteria.\n 2. Psychoactive agents (e.g., benzodiazepines, antidepressants, antipsychotics, amphetamines)\n\nExcluded within 8 weeks prior to study entry:\n\nLong-acting psychoactive agents (e.g., Prozac).\n\n* 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.\n* Positive pregnancy test within 30 days of study entry\n* No abstinence or no agreement to use barrier methods of birth control / contraception during the study"}, 'identificationModule': {'nctId': 'NCT00000392', 'briefTitle': 'Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Mental Health (NIMH)'}, 'officialTitle': 'Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.', 'orgStudyIdInfo': {'id': 'N01 MH00013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Peptide T', 'description': 'Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months', 'interventionNames': ['Drug: Peptide T']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Peptide T', 'type': 'DRUG', 'armGroupLabels': ['Peptide T']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles County - USC Med Ctr', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ of Miami School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}