AIV001 for Relapse

1
Effectiveness
1
Safety
California Dermatology & Clinical Research Institute, Encinitas, CA
+1 More
AIV001 - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Relapse

Study Summary

Safety and Efficacy of AIV001 on Scar Formation and Keloid Recurrence Following Keloidectomy

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Eligible Conditions

  • Relapse
  • Keloid
  • Recurrence

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

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.

365 days
Keloid recurrence
Approximately 365 days
Adverse events

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Control Group
AIV001 Treatment Dose 1

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.

AIV001 Treatment Dose 1
Drug
Intradermal, Dose 1
AIV001 Treatment Dose 2
Drug
Intradermal, Dose 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AIV001
2018
Completed Phase 2
~20

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 365 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 365 days for reporting.

Closest Location

California Dermatology & Clinical Research Institute - Encinitas, CA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male of female, aged 18 to 60, inclusive
No clinically relevant abnormalities identified by a detailed medical history and vital signs
Presence of one keloid scar, up to 2.2 cm length and up to 1.2 cm width, at least 1 year from formation, and located on trunk or arms
Willing to undergo surgical excision of keloid
No concurrent treatment of the study keloid or prior treatment within last 2 months

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes relapse?

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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.

Unverified Answer

What are the signs of relapse?

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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.

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How many people get relapse a year in the United States?

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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.

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Can relapse be cured?

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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.

Unverified Answer

What is relapse?

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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.

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What are common treatments for relapse?

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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.

Unverified Answer

Who should consider clinical trials for relapse?

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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.

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Have there been any new discoveries for treating relapse?

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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.

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What does aiv001 usually treat?

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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.

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Have there been other clinical trials involving aiv001?

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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.

Unverified Answer

What are the common side effects of aiv001?

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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.

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What is aiv001?

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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.

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