A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor

Status Completed

Clinical Trial Summary

To assess the efficacy, safety, and tolerability of recombinant human nerve growth factor ( rhNGF ) in the treatment of HIV-associated sensory neuropathy. AS PER AMENDMENT 5/6/97: To compare the change in viral load between the double-blind phase baseline and week 4 in placebo and active rhNGF recipients. To ensure that rhNGF does not induce an increase in viral load compared with viral load changes seen with placebo. Up to now, treatments for HIV-associated sensory neuropathy have been symptomatic, relying on pain-modifying agents or membrane-stabilizing drugs. Because nerve growth factor is important in the development and maintenance of sympathetic and sensory neurons and their outgrowths, it is proposed that recombinant human nerve growth factor may provide a specific restorative treatment for HIV-associated painful sensory neuropathy.

Clinical Trial Description

Up to now, treatments for HIV-associated sensory neuropathy have been symptomatic, relying on pain-modifying agents or membrane-stabilizing drugs. Because nerve growth factor is important in the development and maintenance of sympathetic and sensory neurons and their outgrowths, it is proposed that recombinant human nerve growth factor may provide a specific restorative treatment for HIV-associated painful sensory neuropathy. Patients are randomized to receive either rhNGF at one of two doses or placebo, administered subcutaneously twice weekly for 18 weeks. Patients are stratified into three groups within their regimens by use of didanosine, zalcitabine, or stavudine as follows: current use vs. discontinued between 8 and 26 weeks before randomization vs. never used or discontinued use at least 26 weeks before randomization. Patients will assess their pain daily using the Gracely Pain Scale. AS PER AMENDMENT 5/6/97: After completion of the double-blind phase (18 weeks on treatment followed by 4 weeks off treatment), patients may receive open-label, active drug treatment according to their previously assigned regimen for an additional 48 weeks. ;

Study Design

Related Conditions & MeSH terms

HIV Infections
Nervous System Diseases
Peripheral Nervous System Disease
Peripheral Nervous System Diseases

Clinical Trial Details

NCT number	NCT00000842
Study type	Interventional
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	Phase 2
Completion date	February 1999

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05454514` - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS	N/A
Completed	`NCT03760458` - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age	Phase 1/Phase 2
Completed	`NCT03141918` - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS	N/A
Completed	`NCT03067285` - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study	Phase 4
Recruiting	`NCT04579146` - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed	`NCT06212531` - Papuan Indigenous Model of Male Circumcision	N/A
Active, not recruiting	`NCT03256422` - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients	Phase 3
Completed	`NCT03256435` - Retention in PrEP Care for African American MSM in Mississippi	N/A
Completed	`NCT00517803` - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies	N/A
Active, not recruiting	`NCT03572335` - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed	`NCT04165200` - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV	N/A
Recruiting	`NCT03854630` - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection	Phase 4
Terminated	`NCT03275571` - HIV, Computerized Depression Therapy & Cognition	N/A
Completed	`NCT02234882` - Study on Pharmacokinetics	Phase 1
Completed	`NCT01618305` - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission	Phase 4
Recruiting	`NCT05043129` - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting	`NCT05536466` - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine	N/A
Recruiting	`NCT04985760` - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy	Phase 1
Completed	`NCT05916989` - Stimulant Use and Methylation in HIV
Terminated	`NCT02116660` - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)	Phase 2

A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms