NAPWA

Who can enrol in this trial?

You may be eligible to participate in this trial if you meet the following criteria:

• At least 18 years old
• Have taken HIV treatments in the past
• Currently taking HIV treatments
• CD4 count at least 300 cells/mm³
• Viral load below 400 copies/ml

This is a summary of key inclusion and exclusion criteria for this trial. There may be other criteria which may exclude some people from participation in this trial. Some laboratory tests may also be required. Consult your doctor, or view the trial protocol or informed consent documentation to see the full range of exclusion and inclusion criteria.

Results:

Although the development of HIV geneThe most basic unit of genetic information. therapy has been slow, there has been some progress. Studies so far have significantly advanced the field of gene-based immunotherapy and these advances have helped to define a series of ongoing and planned trials that may shed light on potential mechanisms for the successful clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. gene therapy of HIV.

Gene transfer has potential as a once-only treatment that reduces viral loadA measurement of the quantity of HIV RNA in the blood. Viral load blood test results are expressed as the number of copies (of HIV) per milliliter of blood plasma., preserves the immune system and avoids lifetime highly active antiretroviralA medication or other substance which is active against retroviruses such as HIV. therapy. This study, which is to our knowledge the first randomized, double-blindA clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study., 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., phase 2A smaller clinical trial designed to establish whether a drug is effective. Phase II studies are conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. If there is evidence that the drug is effective, a Phase III study is undertaken, with a larger number of participaants, to confirm this. cell-delivered gene transfer clinical 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. , was conducted in 74 HIV-1One of two distinct HIV species, HIV-1 is the predominant type in Australia and around the world.-infected adults who received a tat-vpr-specific anti-HIV ribozyme (OZ1) or placeboA dummy medical treatment, designed to have no pharmacological effect, administered to the control group of a clinical trial. delivered in autologous CD34+ hematopoietic progenitor cells.

There were no OZ1-related adverse events. There was no statistically significant difference in viral load between the OZ1 and placebo group at the primary end point (average at weeks 47 and 48), but time-weighted areas under the curve from weeks 40-48 and 40-100 were significantly lower in the OZ1 group. Throughout the 100 weeks, CD4+ lymphocyte counts were higher in the OZ1 group.

This study indicates that cell-delivered gene transfer is safe and biologically active in individuals with HIV and can be developed as a conventional therapeutic product.