The purpose of this study is to determine the safety, tolerability and efficacy of pain relief of recombinant human nerve growth factor (rhNGF) for HIV-associated sensory neuropathy. Five patients were enrolled and active in this clinical trial during the above time period (recruitment started during 8/96). Patients can be randomized to either a low dose rhNGF, a high dose rhNGF or placebo. All five patients have tolerated the study medication well. Two of the patients have reported a benefit in their neuropathy while the other three patients have reported no change. Since 11/30/96, the recruitment for this study continues to grow. We now have 7 patients active in this study and more in the screening process. Nationwide, there are now 147 patients enrolled among 15 sites. At the current rate, the national recruitment goal of 180 participants will be reached by approximately 2/28/97. Due to the rapid accrual rate and to statistical reasons, the study is currently being amended to: 1) increase the number of participants in this study to 260 or 270 and 2) to provide a 48 week open-label phase of this study that would be open to all participants who successfully completed the initial double-blind phase of the study. Participants will either receive low dose or high dose rhNGF during this phase of the trial. No interim analysis has been conducted on the data collected thus far at this point in time.
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