HIV InfectionsPhase 2NCT00000392
Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.
A Phase 2 study testing Peptide T in people with HIV Infections and Cognition Disorders, run by National Institute of Mental Health (NIMH) at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections, Cognition Disorders
- What is being tested?
- Peptide T
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 1990to Aug 1996
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must have:
- Cognitive dysfunction on neuropsychological testing.
- HIV antibody positivity.
- Expected survival of 6 months.
- EITHER no use of an antiretroviral within the past 4 weeks OR use of approved regimens of AZT, ddI, or ddC.
- Medically stable EKG and urinalysis.
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- Given informed, written consent to participate.
- Allowed:
- Inhaled aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis, dapsone, cotrimoxazole, topical antifungal agents, nystatin or ketoconazole, acyclovir.
- 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).
Who cannot join
- Patients with the following are excluded:
- History of mental retardation or learning disability.
- 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.
- 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:
- Kaposi's sarcoma or other malignancy likely to require chemotherapy during the first 6 months of the study.
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- 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.
- Non-HIV related condition that is likely to interfere with interpretation of neuropsychologic test results.
- Inability to participate in neuropsychologic testing or unable to comply with intranasal study medication administration.
- Excluded within 4 weeks prior to study entry:
- Antiretrovirals except as allowed in the Patient Inclusion Criteria.
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Univ of Miami School of Medicine
Miami, Florida, 33136
UCSD
San Diego, California, 92103
About this study
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
- Being tested
- Peptide T, Placebo
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex
- Medical subject headings
- HIV Infections, Cognition Disorders, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptide TDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Peptide T | Active comparator | Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months Receives: Drug: Peptide T |
| Placebo | Placebo comparator | Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global Neurocognitive Performance z Score From Baseline
Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)
Measured: Baseline and 6 months
Secondary outcomes (1)
Change in Neurocognitive Performance Domain z Scores From Baseline
Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2000 (estimated)
- Study startJan 1990
- Primary completionAug 1996
- Study completionAug 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000392
- Sponsor's protocol ID
- N01 MH00013
- Status last verified
- Oct 2013
- First submitted
- 17 Jan 2000
- Last updated
- 28 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 9443710
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.
- ClinicalTrials.gov ID
- NCT00000392
- Acronym / sponsor ID
- N01 MH00013
- Conditions
- HIV Infections, Cognition Disorders
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Jan 1990
- Primary completion
- Aug 1996 (actual)
- Study completion
- Aug 1996 (actual)
- First posted
- 18 Jan 2000 (estimated)
- Results
- Posted 4 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peptide T | Active comparator | Drug: Peptide TPeptide T given intranasally at a dosage of 2mg 3 times a day for 6 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo given intranasally at a dosage of 2mg 3 times a day for 6 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Patients must have:
- Allowed:
- 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
Key exclusion criteria (17 listed)
- Patients with the following are excluded:
- Patients with the following symptoms or conditions are excluded:
- Excluded within 4 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peptide T | Drug | Peptide T |
| Placebo | Drug | Placebo |
Primary outcome
Change in Global Neurocognitive Performance z Score From Baseline
Time frame: Baseline and 6 months
Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)
1 secondary outcome
Change in Neurocognitive Performance Domain z Scores From Baseline
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9443710Heseltine 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peptide T in people with HIV Infections and Cognition Disorders, run by National Institute of Mental Health (NIMH) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Global Neurocognitive Performance z Score From Baseline (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000392, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.