HIV InfectionsNCT00002083
Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS
A study testing Peptide T in people with HIV Infections and Peripheral Nervous System Disease, run by Advanced Peptides at 4 sites in United States.
Trial summary
To compare the effects of intranasal peptide T and placebo in the treatment of painful peripheral neuropathy associated with human immunodeficiency virus (HIV) infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Peripheral Nervous System Disease
- What is being tested?
- Peptide T
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- Documented HIV-1 infection.
- CD4 count < 500 cells/mm3.
- HIV-1-associated distal symmetrical polyneuropathy, with peripheral neuropathy present for at least 6 weeks prior to study entry.
- Pain severity of at least 8 on an analog scale.
- Prior zidovudine therapy for at least the previous 3 months (unless patient has shown intolerance to zidovudine).
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Neuropathy due to any other cause besides HIV infection.
- Any symptom consistent with a new or active underlying opportunistic infection or malignancy that could interfere with the evaluation of neuropathy.
- Clinical evidence of new or active CNS disease, potentially from opportunistic infection or neoplasm resulting from HIV infections, that could interfere with the evaluation of neuropathy.
- Other CNS disease (e.g., myelopathy) that could complicate the evaluation of neuropathy.
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- Active life-threatening illness other than AIDS.
- Concurrent Medication:
- Excluded:
- Dapsone.
- Hydralazine.
- Isoniazid (INH).
- Current use of tricyclic antidepressants, anticonvulsants, or clonidine unless the patient has used the drug without a change in dose for at least 3 months prior to study entry.
- Narcotics, unless the patient has been using them for at least 6 weeks prior to study entry.
- Prior Medication:
- Excluded:
- ddI or ddC in the past 8 weeks.
- Prior peptide T.
- Prior tricyclic antidepressants, anticonvulsants, or clonidine unless they have been used for at least 3 months without change in dose.
- Other investigational drugs within the past 30 days.
- Required:
- Zidovudine (if intolerance not demonstrated).
- Required:
- Zidovudine for at least the previous 3 months (unless patient has demonstrated intolerance to zidovudine).
- Chronic alcohol abuse, or current abuse of psychoactive recreational drugs as defined in DSM IIIR. Patients who may be regarded as unreliable for the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Univ of Miami School of Medicine
Miami, Florida, 33136
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019
Mount Sinai Med Ctr / Klingenstein Clinical Ctr
New York, New York, 10029
Columbia Presbyterian Med Ctr
New York, New York, 10032
About this study
To compare the effects of intranasal peptide T and placebo in the treatment of painful peripheral neuropathy associated with human immunodeficiency virus (HIV) infection.
- Conditions
- HIV Infections, Peripheral Nervous System Disease
- Being tested
- Peptide T
- Keywords
- Peptide T, HIV-1, Administration, Intranasal, Acquired Immunodeficiency Syndrome, Peripheral Nervous System Diseases
- Medical subject headings
- HIV Infections, Peripheral Nervous System Diseases, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptide TDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Advanced Peptides
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002083
- Sponsor's protocol ID
- 115A
- Other IDs
- 01
- Status last verified
- Mar 1993
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
MacFadden DK, Doob PR. Role of peptide T in palliation of HIV-1-related painful peripheral neuropathy. Int Conf AIDS. 1991 Jun 16-21;7(2):225 (abstract no WB2173)
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS
- ClinicalTrials.gov ID
- NCT00002083
- Acronym / sponsor ID
- 115A
- Conditions
- HIV Infections, Peripheral Nervous System Disease
- Keywords
- Peptide T, HIV-1, Administration, Intranasal, Acquired Immunodeficiency Syndrome, Peripheral Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Advanced PeptidesIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effects of intranasal peptide T and placebo in the treatment of painful peripheral neuropathy associated with human immunodeficiency virus (HIV) infection.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented HIV-1 infection.
- CD4 count < 500 cells/mm3.
- HIV-1-associated distal symmetrical polyneuropathy, with peripheral neuropathy present for at least 6 weeks prior to study entry.
- Pain severity of at least 8 on an analog scale.
- Prior zidovudine therapy for at least the previous 3 months (unless patient has shown intolerance to zidovudine).
Key exclusion criteria (25 listed)
- Neuropathy due to any other cause besides HIV infection.
- Any symptom consistent with a new or active underlying opportunistic infection or malignancy that could interfere with the evaluation of neuropathy.
- Clinical evidence of new or active CNS disease, potentially from opportunistic infection or neoplasm resulting from HIV infections, that could interfere with the evaluation of neuropathy.
- Other CNS disease (e.g., myelopathy) that could complicate the evaluation of neuropathy.
- Active life-threatening illness other than AIDS.
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 | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- BackgroundMacFadden DK, Doob PR. Role of peptide T in palliation of HIV-1-related painful peripheral neuropathy. Int Conf AIDS. 1991 Jun 16-21;7(2):225 (abstract no WB2173)
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peptide T in people with HIV Infections and Peripheral Nervous System Disease, run by Advanced Peptides at 4 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 6 inclusion and 25 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002083, 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 24 Jun 2005.