HIV InfectionsPhase 2NCT00528593
Epoetin Alfa for HIV-Associated Neuropathy Trial
A Phase 2 study testing epoetin alfa in people with HIV Infections and Neuropathy, run by Washington University School of Medicine.
Trial summary
The purpose of this study is to evaluate the effect of epoetin alfa on HIV-associated neuropathy by measuring changes in nerve fiber density and pain ratings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Neuropathy
- What is being tested?
- epoetin alfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Oct 2009
- Phase
- Phase 2
- 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
- Subject is a male or female ≥ 18 years old.
- Subject has documented HIV-1 infection.
- Subject has stable use or no use of specific dideoxynucleoside reverse transcriptase inhibitors (ie. ddI, d4T, ddc) for ≥4 months prior to Visit 1.
- Subject has painful HIV-associated sensory neuropathy (either DSP or ATN), as confirmed by a neurologist.
- Subject has an average severity of neuropathic pain over the 2 week period between visit 2 and Visit 3 of ≥0.74 units measured with the Gracely pain intensity scale.
- Subject (either male or female) agrees not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and use of contraception.
- Subjects hemoglobin is less than 13.0g/dl but greater than or equal to 10.0g/dl.
Who cannot join
- Subject has any condition other than HIV infection or antiretroviral therapy that in the opinion of the site neurologist confounds the diagnosis of neuropathy.
- Subject has received insulin or oral hypoglycemic products for treatment of diabetes mellitus £30 days from Visit 1.
- Subject has a documented history of untreated vitamin B12 deficiency (serum B12 level less than 200 pg/mL) or less than 3 months of B12 supplementation (injection or intranasal B12) prior to screening. Use of a multivitamin is permissible.
- Subject has hereditary neuropathy or compression-related neuropathies, i.e. spinal stenosis, that would preclude analysis of treatment response.
- Subject has received treatment with any drug other than the dideoxynucleoside analogues that the site neurologist considers to have significantly contributed to the subject's neuropathy ≤30 days from Visit 1.
- Subject has a history of any alcohol-related medical complications within 6 months of Visit 1 including, but not limited to, alcohol withdrawal seizures, hallucinosis, delirium tremens, or being in a detoxification program.
Show all 25Show fewer
- Subject has received neurotoxic chemotherapeutic agents £90 days from Visit 1.
- Subject has received neuroregenerative agents £90 days from Visit 1.
- Subject has myelopathy that would interfere with the evaluation of the subject.
- Subject has uncontrolled hypertension (Systolic Bp>160mmHg and/or Diastolic Bp >100mmHg)
- Subject has known hypersensitivity to mammalian cell-derived products or albumin.
- Subject has a history of thrombotic events or epileptic seizures.
- Subject has an active AIDS-defining opportunistic infection (OI) or OI-defining condition £30 days from Visit 1.
- Subject has active major disease, both HIV-related and non-HIV-related including, but not limited to, cardiac disease, pulmonary, or hepatorenal, which in the opinion of the investigator might affect the study.
- Subject is pregnant or breast-feeding.
- Subject has any currently active malignancy, or a history of any previous malignancy with the exception of skin squamous cell carcinoma or basal cell carcinoma.
- Subject has received any investigational agent(s) that is not FDA-approved or has participated in any interventional research study £30 days from Visit 1.
- Subject is actively using recreational intravenous drugs, crack cocaine, or intranasal/smoked heroin or methamphetamine.
- Subject has chronic renal failure defined for the purposes of this study as a creatinine >1.5 x upper limit of normal (ULN).
- Subject has hepatitis C and is on interferon/ribavirin therapy or interferon/ribavirin therapy is planned over the expected course of the study.
- Subject has received epoetin alfa (Procrit) within 2 months prior to study entry.
- Subject has HgbA1C >6.5.
- Subject has serum B12 ≤200 pg/mL.
- Subject has hemoglobin <11.0 g/dL.
- Subject has INR >1.4 or platelets <50,000.
About this study
Official title: A Randomized, Multi-center Pilot Study to Evaluate the Efficacy and Safety of Epoetin Alfa (Procrit) in the Treatment of HIV-associated Sensory Neuropathy
The purpose of this study is to evaluate the effect of epoetin alfa on HIV-associated neuropathy by measuring changes in nerve fiber density and pain ratings.
Read the detailed description
The Neurologic AIDS Research Consortium (NARC) designs and carries out clinical trials to improve the therapy for HIV induced neurologic disease, and neurologic conditions associated with the AIDS virus.
Complications of HIV are dynamically evolving over time. In general, neurologic complications that typically occur in advanced disease stages are increasing in incidence while some of the early complications associated with AIDS are less commonly found due to improved preventive therapy. The impact of the new generation of antiretroviral drugs, and of predominantly multi-drug therapy remain to be seen. Several key new drugs fail to penetrate the brain, thus making it possible for the incidence of neurologic disease to continue to increase. NARC develops studies based on the current challenges of the AIDS epidemic.
Erythropoetin (also known as epoetin alfa or Procrit) is naturally produced in the body. Procrit or epoetin alfa is an injectable form of synthetic erythropoietin. In this trial, scientists will evaluate the effect of epoetin alfa on HIV-associated neuropathy by measuring changes in nerve fiber density and pain ratings. The goal of the trial is to determine if epoetin alfa increases the number of nerve fibers in the skin of people with HIV-associated neuropathy, and improves symptoms of neuropathy. This study will also find out if Procrit is safe and well-tolerated for treating the painful neuropathy associated with HIV.
After two screening visits, participants will be randomly assigned to one of two groups: group 1 will receive Procrit once every three weeks, and group 2 will receive Procrit every week. Follow-up treatment visits will occur at weeks 6, 12, 24, 36, and 48. During the visits, participants will have their blood pressure and heart rate measured. During several of the follow-up visits participants will be asked to rate the intensity of their pain using the Gracely Pain Scale and the McGill Pain Questionnaire. Duration of this trial for participants is 52 weeks or 1 year.
- Conditions
- HIV Infections, Neuropathy
- Being tested
- epoetin alfa
- Keywords
- HIV, AIDS, neuropathy, Procrit, epoetin alfa, erythropoetin, Treatment Experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin alfaDrug
Also called Procrit, erythropoetin
Group 1 will receive Procrit once every three weeks, and group 2 will receive Procrit every week.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: epoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the distal leg intra-epidermal nerve fiber density
Measured: at baseline and after 48 weeks of treatment
Secondary outcomes (3)
Change in pain levels measured via Gracely pain scale between baseline and every 6 weeks thereafter up to 48 weeks
Measured: up to 48 weeks
Change in global physician impression from the Visit 4 baseline measurement and measurement after 48 weeks of treatment
Measured: baseline and after 48 weeks of treatment
Differences between Quantitative Sensory Testing measurement at baseline and after 48 weeks of treatment
Measured: at baseline and after 48 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startNov 2007
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: lack of pharmaceutical support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Biotech Clinical Affairs, L.L.C., PPD Development, LP, National Institute of Neurological Disorders and Stroke (NINDS)
- Investigators
- Justin McArthur, MBBS, MPH, Study chair, Professor of Neurology, Johns Hopkins UniversityDavid B. Clifford, MD, Principal investigator, Professor of Neurology, Washington UniversityDavid Simpson, MD, Principal investigator, Professor of Neurology, Mt. Sinai Medical CenterBruce Cohen, MD, Principal investigator, Professor of Neurology, Northwestern UniversityPablo Tebas, MD, Principal investigator, Associate Professor of Medicine, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528593
- Sponsor's protocol ID
- U01 NS32228- ninds
- Other IDs
- U01NS032228
- Status last verified
- Aug 2011
- First submitted
- 11 Sep 2007
- Last updated
- 9 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center Pilot Study to Evaluate the Efficacy and Safety of Epoetin Alfa (Procrit) in the Treatment of HIV-associated Sensory Neuropathy
- ClinicalTrials.gov ID
- NCT00528593
- Acronym / sponsor ID
- U01 NS32228- ninds
- Conditions
- HIV Infections, Neuropathy
- Keywords
- HIV, AIDS, neuropathy, Procrit, epoetin alfa, erythropoetin, Treatment Experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of pharmaceutical support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Ortho Biotech Clinical Affairs, L.L.C., PPD Development, LP, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Nov 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 12 Sep 2007 (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.
The purpose of this study is to evaluate the effect of epoetin alfa on HIV-associated neuropathy by measuring changes in nerve fiber density and pain ratings.
Detailed description
The Neurologic AIDS Research Consortium (NARC) designs and carries out clinical trials to improve the therapy for HIV induced neurologic disease, and neurologic conditions associated with the AIDS virus.
Complications of HIV are dynamically evolving over time. In general, neurologic complications that typically occur in advanced disease stages are increasing in incidence while some of the early complications associated with AIDS are less commonly found due to improved preventive therapy. The impact of the new generation of antiretroviral drugs, and of predominantly multi-drug therapy remain to be seen. Several key new drugs fail to penetrate the brain, thus making it possible for the incidence of neurologic disease to continue to increase. NARC develops studies based on the current challenges of the AIDS epidemic.
Erythropoetin (also known as epoetin alfa or Procrit) is naturally produced in the body. Procrit or epoetin alfa is an injectable form of synthetic erythropoietin. In this trial, scientists will evaluate the effect of epoetin alfa on HIV-associated neuropathy by measuring changes in nerve fiber density and pain ratings. The goal of the trial is to determine if epoetin alfa increases the number of nerve fibers in the skin of people with HIV-associated neuropathy, and improves symptoms of neuropathy. This study will also find out if Procrit is safe and well-tolerated for treating the painful neuropathy associated with HIV.
After two screening visits, participants will be randomly assigned to one of two groups: group 1 will receive Procrit once every three weeks, and group 2 will receive Procrit every week. Follow-up treatment visits will occur at weeks 6, 12, 24, 36, and 48. During the visits, participants will have their blood pressure and heart rate measured. During several of the follow-up visits participants will be asked to rate the intensity of their pain using the Gracely Pain Scale and the McGill Pain Questionnaire. Duration of this trial for participants is 52 weeks or 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: epoetin alfa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is a male or female ≥ 18 years old.
- Subject has documented HIV-1 infection.
- Subject has stable use or no use of specific dideoxynucleoside reverse transcriptase inhibitors (ie. ddI, d4T, ddc) for ≥4 months prior to Visit 1.
- Subject has painful HIV-associated sensory neuropathy (either DSP or ATN), as confirmed by a neurologist.
- Subject has an average severity of neuropathic pain over the 2 week period between visit 2 and Visit 3 of ≥0.74 units measured with the Gracely pain intensity scale.
Key exclusion criteria (25 listed)
- Subject has any condition other than HIV infection or antiretroviral therapy that in the opinion of the site neurologist confounds the diagnosis of neuropathy.
- Subject has received insulin or oral hypoglycemic products for treatment of diabetes mellitus £30 days from Visit 1.
- Subject has a documented history of untreated vitamin B12 deficiency (serum B12 level less than 200 pg/mL) or less than 3 months of B12 supplementation (injection or intranasal B12) prior to screening. Use of a multivitamin is permissible.
- Subject has hereditary neuropathy or compression-related neuropathies, i.e. spinal stenosis, that would preclude analysis of treatment response.
- Subject has received treatment with any drug other than the dideoxynucleoside analogues that the site neurologist considers to have significantly contributed to the subject's neuropathy ≤30 days from Visit 1.
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 |
|---|---|---|
| epoetin alfaAlso: Procrit, erythropoetinGroup 1 will receive Procrit once every three weeks, and group 2 will receive Procrit every week. | Drug | 1 |
Primary outcome
Difference between the distal leg intra-epidermal nerve fiber density
Time frame: at baseline and after 48 weeks of treatment
3 secondary outcomes
Change in pain levels measured via Gracely pain scale between baseline and every 6 weeks thereafter up to 48 weeks
Time frame: up to 48 weeks
Change in global physician impression from the Visit 4 baseline measurement and measurement after 48 weeks of treatment
Time frame: baseline and after 48 weeks of treatment
Differences between Quantitative Sensory Testing measurement at baseline and after 48 weeks of treatment
Time frame: at baseline and after 48 weeks of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
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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.
Justin McArthur, MBBS, MPH study chair
Professor of Neurology, Johns Hopkins University
David B. Clifford, MD principal investigator
Professor of Neurology, Washington University
David Simpson, MD principal investigator
Professor of Neurology, Mt. Sinai Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing epoetin alfa in people with HIV Infections and Neuropathy, run by Washington University School of Medicine.
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 7 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: withdrawn, as of the sponsor's last update on 9 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Difference between the distal leg intra-epidermal nerve fiber density (time frame: at baseline and after 48 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2011.