NAPWA

About this trial

This is a one-year extension studyA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. to investigate the long-term safety, tolerability and efficacy(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it. of open labelA clinical trial in which doctors and participants know which drug or vaccine is being administered. flupirtine for the treatment of painful HIV Sensory Neuropathy (HIV-SN)in patients who have pain inadequately controlled by opioids.

Background information

Painful HIV-SN is a neurological complication of HIV infection that can result from either the HIV disease process itself and/or from the use of some of the anti-retroviral medications that are used to treat HIV. There has been considerable research into the treatment of painful HIV-SN neuropathy. However, treatment with currently available pain killing medications rarely renders the patient pain free and the use of medications may be limited by side effects.

This current research project is only being offered to the participants who have taken part in the previous research project entitled “A placebo controlledA method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition. multiple dose research project of Flupirtine for the treatment of painful HIV-SN”. Study subjects who did not complete CNSBio 01/7 may be enrolledThe act of signing up participants into a study. Generally this process involves evaluating a participant with respect to the eligibility criteria of the study and going through the informed consent process. in this study with the approval of the Principle InvestigatorA medical researcher in charge of carrying out a clinical trial's protocol. and the Sponsor.

The previous study has the protocolA study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment number CNSBio 01/07. “CNSBio 01/07” is investigating the short-term (one week) effectiveness(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it. and safety of the pain killing medication Flupirtine when taken in combination with opioids for the treatment of painful HIV-SN. CNSBio 01/07 is not yet completed and the results of this clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. are not yet available.

The purpose of this research project is to investigate further if the drug Flupirtine is a safe and effective treatment for HIV-SN when taken in combination with opioids for longer than a week (up to one year).

Flupirtine is an experimental(Of a drug) Not licensed for use in humans, or as a treatment for a particular condition. Experimental drugs are studied in clinical trials to determine their safety and efficacy, and are sometimes made available via Special Access Schemes prior to their approval. treatment. This means that currently the drug is not an approved treatment for painful HIV-SN in the United States by the Food and Drug Administration (FDAThe U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices, including those used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA also works with the blood banking industry to safeguard the nation's blood supply. The Australian equivalent is the Therapeutic Goods Administration (TGA).) or in Australia by the Therapeutic Goods Administration (TGA[Therapeutic Goods Administration] The federal government body that approves drugs and treatments before they can be prescribed.). It is however approved for the treatment of back pain, muscle stiffness and pain associated with surgery and arthritis in Germany, Russia, Portugal, China and Brazil. CNSBio Pty Ltd is sponsoring the current research project with the aim of developing Flupirtine for the treatment of painful HIV-SN in Australia and America if flupirtine proves to be safe and effective in this context.