HIV InfectionsPhase 2NCT00002160
A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain
A Phase 2 study testing Ziconotide in people with HIV Infections and Cancer, run by Neurex at 44 sites in United States.
Trial summary
To determine the safety and efficacy of SNX-111 in controlling severe, chronic pain in cancer and AIDS patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Cancer, Pain
- What is being tested?
- Ziconotide
- How many people
- 100 participants
- Where
- 44 sitesUnited States
- Study dates
- Start not givento not given
- 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
- Concurrent Medication:
- Allowed:
- Rescue analgesia.
- Patients must have:
- Chronic pain related to AIDS or cancer.
- Unsatisfactory response to prior opioid therapy.
- Life expectancy > 3 months (or 1 month if an infusion pump is in place).
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Signs of sepsis or inadequately treated infection.
- Patients with the following prior conditions are excluded:
- History of heart disease, heart failure, or asthma.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Lehigh Valley Hosp
Allentown, Pennsylvania, 18104
Emory Univ Hosp
Atlanta, Georgia, 30322
Johns Hopkins Hosp
Baltimore, Maryland, 21205
Alta Bates Hosp
Berkeley, California, 94704
Brigham and Women's Hosp
Boston, Massachusetts, 02115
Cooper Hospital Early Intervention Program
Camden, New Jersey, 08103
Cook County Hosp
Chicago, Illinois, 60612
Pain Control Ctr
Chicago, Illinois, 60612
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Univ of Missouri Med Ctr
Columbia, Missouri, 65212
Connecticut Pain Care
Danbury, Connecticut, 06810
Elkhardt Gen Hosp
Elkhardt, Indiana, 46514
Fairfax Hosp
Falls Church, Virginia, 220423300
Holt Krock Clinic
Fort Smith, Arkansas, 72901
Pain Diagnosis and Treatment
Glendora, California, 917414240
Pennsylvania State College of Medicine
Hershey, Pennsylvania, 17033
Ctr for Pain Management and Rehabilitation
Huntsville, Alabama, 35801
Univ of Iowa Hosp
Iowa City, Iowa, 522421061
Univ of Kansas Med Ctr
Kansas City, Kansas, 661607415
The Pain Institute
Kansas City, Missouri, 64132
New Orleans Pharmaceutical Research
Kenner, Louisiana, 70062
Texas Tech Univ Health Science Ctr
Lubbock, Texas, 79430
Marschfield Clinic
Marshfield, Wisconsin, 544495777
Methodist Hosp
Memphis, Tennessee, 38104
Univ of Tennessee
Memphis, Tennessee, 38163
Univ of Miami School of Medicine
Miami, Florida, 33136
Minneapolis Veterans Administration
Minneapolis, Minnesota, 55417
Gulf Coast Clinical Services
Mobile, Alabama, 36603
Pain Management
New York, New York, 10021
Northport Hosp
Northport, Alabama, 35476
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 19107
Long Island Pain Management
Port Jefferson Station, New York, 11776
Clinical Solutions
Princeton, New Jersey, 08540
Univ of Rochester
Rochester, New York, 14642
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 782847838
Univ of CA - San Diego
San Diego, California, 921038770
Good Samaritan Hosp Ctr
San Jose, California, 95124
Swedish Pain Management
Seattle, Washington, 98104
Northwest Neuroscience Institute
Seattle, Washington, 98133
Louisiana State Univ
Shreveport, Louisiana, 711303932
H Lee Moffit Cancer Ctr and Research Institute
Tampa, Florida, 33612
Neurosurgical Associates
Terre Haute, Indiana, 47804
VA Med Ctr / Oncology Section
Washington D.C., District of Columbia, 20422
Bowman Gray School of Medicine / Wake Forest Univ
Winston-Salem, North Carolina, 27157
About this study
To determine the safety and efficacy of SNX-111 in controlling severe, chronic pain in cancer and AIDS patients.
Read the detailed description
Patients are randomized to receive SNX-111 or placebo (AS PER AMENDMENT 1/22/98: with randomization weighted 2:1 in favor of SNX-111) via external pump and an intrathecal catheter (thin tube inserted into the spinal canal). (AS PER AMENDMENT 1/22/98: the dose is increased every 24 hours, in the absence of onset of analgesia or adverse events. After 2-5 days, patients who respond to their medication continue treatment at home for 5-8 days. Patients who do not respond will be switched to the other regimen (i.e., placebo to SNX-111, or SNX-111 to placebo). After 10 days, responding patients are unblinded and asked to enroll in the long-term, open-label extension protocol. Patients remain on a fixed dose at the therapeutic level found in the previous study. The dose may be increased or decreased at the discretion of the investigator. Patients may continue therapy on a long-term basis until the drug is approved.
- Conditions
- HIV Infections, Cancer, Pain
- Being tested
- Ziconotide
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Pain, Palliative Care, omega-conopeptide MVIIA, Calcium Channel Blockers
- Medical subject headings
- HIV Infections, Neoplasms, Pain, 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.
ZiconotideDrug
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.
- 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 2
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Neurex
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002160
- Sponsor's protocol ID
- 256A
- Status last verified
- Mar 1998
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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
- A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT00002160
- Acronym / sponsor ID
- 256A
- Conditions
- HIV Infections, Cancer, Pain
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Pain, Palliative Care, omega-conopeptide MVIIA, Calcium Channel Blockers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- NeurexIndustry (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 determine the safety and efficacy of SNX-111 in controlling severe, chronic pain in cancer and AIDS patients.
Detailed description
Patients are randomized to receive SNX-111 or placebo (AS PER AMENDMENT 1/22/98: with randomization weighted 2:1 in favor of SNX-111) via external pump and an intrathecal catheter (thin tube inserted into the spinal canal). (AS PER AMENDMENT 1/22/98: the dose is increased every 24 hours, in the absence of onset of analgesia or adverse events. After 2-5 days, patients who respond to their medication continue treatment at home for 5-8 days. Patients who do not respond will be switched to the other regimen (i.e., placebo to SNX-111, or SNX-111 to placebo). After 10 days, responding patients are unblinded and asked to enroll in the long-term, open-label extension protocol. Patients remain on a fixed dose at the therapeutic level found in the previous study. The dose may be increased or decreased at the discretion of the investigator. Patients may continue therapy on a long-term basis until the drug is approved.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Rescue analgesia.
- Chronic pain related to AIDS or cancer.
- Unsatisfactory response to prior opioid therapy.
- Life expectancy > 3 months (or 1 month if an infusion pump is in place).
Key exclusion criteria (5 listed)
- Signs of sepsis or inadequately treated infection.
- History of heart disease, heart failure, or asthma.
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 |
|---|---|---|
| Ziconotide | 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.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
44 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 Ziconotide in people with HIV Infections and Cancer, run by Neurex at 44 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 7 inclusion and 5 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 44 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.
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 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?
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.