This trial is evaluating whether AIV001 will improve 1 primary outcome and 1 secondary outcome in patients with Relapse. Measurement will happen over the course of Approximately 365 days.
This trial requires 30 total participants across 2 different treatment groups
This trial involves 2 different treatments. AIV001 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
Relapse to smoking can be triggered by the buildup of harmful substances from smoking into the bloodstream, which also impacts remission. This is termed the'second hit effect.' Smoking-related health promotion practices can be a crucial component of relapse prevention. We encourage smokers to stop smoking in order to avoid the second hit to their health.
The signs of relapse include exacerbation of depressive symptoms, hyperactivity, restlessness and a feeling of powerlessness. Patients need to be aware of the signs of relapse so that they can initiate appropriate treatment as soon as possible.
The American Cancer Society estimates a 15% relapse rate per year among patients who survive primary treatment. This rate drops to only 2% a year for patients who survive treatment for only the primary disease. These observations suggest that the use of standard therapies after relapse may be less effective in suppressing the disease.
Relapses during treatment for acute manic episodes are rare and are the result of an acute change in psychiatric status. However, relapse during treatment for depressive episodes (recurrent episodes or re-budding of bipolar depression) is more likely and requires careful management with a goal of reducing the intensity of symptoms.
Relapse can vary dramatically. Relapse rates after a treatment episode can be as high as 72%, or as low as 4% depending on the definition of relapse used.
There is no treatment for acute relapse of arthritis. Analgesics are used for mild to moderate pain before, during, and after physical therapy. In severe cases, oral and injectable corticosteroids with or without NSAIDs are also typically used. Other treatment strategies may be utilized during an acute relapse, including intraarticular injections and an intraarticular corticosteroid washout. A review of the literature is presented, including case reports and experience with treatment of rheumatoid arthritis before, during, and after an acute arthritis relap.
Younger patients with newly diagnosed or recurrent NHL had a higher rate of relapse, and a lower disease-free survival, compared to those who had not been treated for relapse. In addition, in the recurrent group older subjects had a shorter time to relapse and shorter duration of disease-free survival, as compared to younger subjects. Clinicians should consider clinical trials for relapse in young patients, despite their lack of response to therapy.
There has been significant scientific advances in our understanding of relapse mechanisms. In general, relapse of multiple myeloma is multifactorial and a complex process. There are many therapeutic targets with regard to relapse prevention.
Data from a recent study suggest that only those patients with moderate or worse depression, moderate to severe anxiety that is not controllable with pharmacological medication, and a significant degree of disability/symptoms might benefit from treatment with Aiv001.
The current FDA label of aiv001 reads: "[The FDA considers] this product to potentially have the potential to cause a significant interaction with, or be an interaction with, a prescription drug." No other manufacturers of aiv001 are known to be conducting a similar clinical program. However, there are multiple open-label studies on other drugs in human clinical development that have similar safety profiles. Given the lack of data to support any specific interaction with aiv001, the safety profile for aiv001 appears to be the same as for any pharmaceutical drug. Thus, the FDA does not consider aiv001 to be likely to interact with any specific drug. There also exist no reports to suggest any interactions with other medical devices or equipment.
Findings from a recent study suggest that the common side effects of aiv001 may be due to the drug itself or the dosing protocol, and that they are all reversible.
In summary, Aiv001 is an interesting candidate for therapy of NSCLC, but further preclinical evaluations are needed to identify the most appropriate pharmacological dosage and mode of administration of Aiv001.