Safety and Efficacy Study of Prosaptide to Treat Neuropathic Pain in HIV-Positive Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00286377 |
Recruitment Status :
Terminated
First Posted : February 3, 2006
Last Update Posted : February 3, 2006
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Peripheral Nervous System Disorders | Drug: prosaptide | Phase 2 |
Sensory neruopathies are the most frequent neurological complicaton of HIV infection and its treatmet with antiretrovirals. To date, there are few effective treatments, and all are symptomatic treatments for pain. Management typically involves the intiation and adjustment of pain-modifying therapies, and the adjustment or discontinuation of potentially neurotoxic antiretrovirals, thereby limiting the choice of HAART regimens.
In precinical animal models,prosaptide has been shown to be efficacious in the treatment of neuropathic pain caused by a variety of different mechanisms.
Hypothesis: Prosaptide will improve neuropathic pain in HIV-associated sensory neuroathies,and will be safe and well tolerated in subjects.
Comparisons: 4, 8, or 16 mg prosaptide vs. placebo
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 350 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy and Safety of Prosaptide Over 6 Weeks of Treatment for the Relief of Neuropathic Pain Associated With HIV-1 |
Study Start Date : | September 2003 |
Study Completion Date : | December 2004 |
- Differnece between the pain rating at Baseline vs. Week 6 (or last week)of treatment, based on the 13-point Gracely pain intensity scale as rated by subjects and captured in an electronic diary
- Difference between the Beline pain rating and each week of treatment.
- Number of subjects whoe were treatment successes at each week of the active treatment period.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ages 18 years and older

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286377
Study Director: | Claudia Rehrig, MS | Savient Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00286377 |
Other Study ID Numbers: |
C0603 NARC # 009 |
First Posted: | February 3, 2006 Key Record Dates |
Last Update Posted: | February 3, 2006 |
Last Verified: | January 2006 |
Neuralgia Nervous System Diseases Peripheral Nervous System Diseases |
Neuromuscular Diseases Pain Neurologic Manifestations |