Posts Tagged Clinical Trials

HIV Thai Phase III Update

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Experimental HIV Vaccine Prevents Infection in Nearly 1/3 of Subjects

Researchers optimistic, but questions remain

On Thursday, September 24, 2009, The Surgeon General of the U.S. Army released results from the Thai Phase III HIV vaccine study that demonstrated modest results in preventing HIV infection among participants in the clinical trial. The study found the vaccine regimen to be safe and 31 percent effective in preventing HIV infection.

The potential breakthrough comes after several failed vaccine trials; many scientists believed an HIV vaccine might not be possible. For the first time, however, the Thai Phase III study used the combination of two vaccines, Sanofi Pasteur’s ALVAC vaccine and the AIDSVAX B/E vaccine, developed by Vaxgen Inc. and licensed to the nonprofit Global Solutions for Infectious Diseases (GSID) in 2008. The research was sponsored jointly by the U.S. Army and the National Institute of Allergy and Infectious Diseases (NIAID), along with Sanofi Pasteur and GSID.

The study, conducted in two Thai provinces, began in October 2003 and involved approximately 16,402 HIV-negative subjects ages 18-30 at various levels of risk for HIV infection. Trial participants were evenly divided into groups and received either the vaccine or placebo upon enrollment in the study and again after 1 month, 3 months, and 6 months. Participants were counseled on HIV risk reduction strategies and tested for the virus twice a year for three years. Among the 8,197 subjects who received the combination of vaccines, 51 contracted HIV during the study. This compares to 74 of the 8,198 participants in the placebo group who became infected with the virus. Those who became HIV-positive during the study have been offered treatment at no cost.

In a press release, Anthony S Fauci, M.D. and Director of the National Institute of Allergy and Infectious Diseases, acknowledges these new findings as “an important step forward in HIV vaccine research,” but cautions that “additional research is needed to better understand how this vaccine regimen reduced the risk of HIV infection.”

The United Nations Joint Programme on HIV/AIDS estimates that 7,000 people worldwide are newly infected with HIV everyday; 2 million people died of AIDS in 2007. There is much to consider regarding future HIV vaccine research. Yet, after more than two decades, the search for a safe, effective vaccine that protects against HIV infection has made an encouraging advance.

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HIV Vaccine Regimen Demonstrates Modest Preventive Effect in Thailand Clinical Study

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In an encouraging development, an investigational vaccine regimen has been shown to be well-tolerated and to prevent HIV infection in a clinical trial involving more than 16,000 adult participants in Thailand.

Following a final analysis of the trial data, the Surgeon General of the U.S. Army, the trial sponsor, announced today that the prime-boost investigational vaccine regimen was safe and 31 percent effective in preventing HIV infection.

“These new findings represent an important step forward in HIV vaccine research,” says Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, which provided major funding and other support for the study.

“For the first time, an investigational HIV vaccine has demonstrated some ability to prevent HIV infection among vaccinated individuals. Additional research is needed to better understand how this vaccine regimen reduced the risk of HIV infection, but certainly this is an encouraging advance for the HIV vaccine field.”

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Genital Herpes Clinical Research Study

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Astellas-bannerANIM

Do you have genital herpes? A clinical research study is being conducted to evaluate an investigational medication for genital herpes. To qualify you must:

Be at least 18 years of age (if you live in Alabama, you must
be at least 19)
Be diagnosed with genital herpes
Have had at least 4 outbreaks in the past year

All study-related examinations, lab tests, and the study medication are provided to qualified participants at no cost. Qualified participants will also receive compensation for time and travel. For more information, please call 1-800-438-5260 or visit www.ashastd.org/trial.cfm.

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There might be a vaccine for Chlamydia in 2010

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Scientists in Australia are one step closer to discovering a vaccine for the common sexually-transmitted infection, chlamydia. A team from Queensland University of Technology and Harvard Medical School has already identified proteins that are able to protect against chlamydia and plan to breed mice with these immune fighting cells.

These cells, known as T-cells will be specifically directed to protect against the mouse strain of chlamydia. In doing so, they’ll be able to learn about what is involved in protecting mice against chlamydia infection and then duplicate those responses with vaccines.

“We’ve been testing these proteins as part of animal trials…and we think we’ve got the answer. It is possible that within three to five years we’ll be finished the animal trials and be looking at clinical trials in humans,” said Professor Peter Timms, from QUT’s Institute of Health and Biomedical Innovation (IHBI).

With 3 million new cases per year, Chlamydia is the most commonly reported STI in the U.S., especially among teens and young adults. The infection can be particularly dangerous for women, as many experience few or no symptoms and are unaware of their infection. Left untreated, chlamydia can cause serious complications and irreversible damage, including infertility.

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Where is the best place to get information on recent development in the field of fighting herpes infection?

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Herpes Question:

Where is the best place to get information on recent development in the field of fighting herpes infection? I’d be interested in signing up for clinical trials, as well as reading about recent discoveries, but I don’t know where to start?

Herpes Answer:

ClinicalTrials.gov

CenterWatch.com

Medline Plus Clinical Trials

These are all great resources. All I did was do a Google search for the keywords “Clinical Trials” and that is what I come up with. I am familiar with the CenterWatch.com site as that is one that I have used over the years.

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The President of Imulux has something to say

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Open Letter to all past, current and future users of the Imulux protocol.

My name is Dr. Jon Stoneburner, President and owner of Imulux Ltd.. I was appointed to the position of Professor of Energy Medicine at the Institute of Progressive Medicine in 2005 by its founder Dr. John Martin and have co authored published clinical trials that appear in Principals of Molecular Pathology. I have been appointed the position of “clinical investigator” buy the IRB (Institutional Review Board) under an IND (Investigational New Drug) permit granted by the FDA (Food and Drug Administration) in April of 2006.

There has been a lot of talk in the herpes community regarding Imulux. I would like to clarify our claims and position on the Imulux protocol so that there is no misunderstanding.

IMULUX CLAIM

No one on the face of the planet can claim to have a “cure” for herpes but we at Imulux feel that we might have the closest thing to it.

  • We claim that the Imulux protocol kills viruses allowing the body to form antibodies. Your immune system is what protects you from that point forward.
  • We claim according to clinical trials that patients consistently report immediate relief of symptoms associated with their outbreak and expedited healing of their lesion following application of the Imulux protocol.

ADDITIONAL INFO

Science will agree with the following facts:

  • ULTRAVIOLET LIGHT IS “HAZARADIOUS TO THE HEALTH OF VIRUSES”, they do not survive well in its presence.
  • IF MEDICINE INJECTS DEAD VIRUSES INTO THE BODY THE BODY WILL FORM ANTIBODIES. (EXAMPLE; A FLU SHOT)

Scientists at Imulux have found a solution that allows ultraviolet light to pass through the skin unaltered in wavelength or intensity. We call this solution a “photon lending substance”. The substance involved is not a drug, medication, or strong chemical with hazardous side effects. In fact it is classified by the FDA as a class one Medical Device. This substance is readily absorbed by the virus and when exposed to ultraviolet light causes damage to the virus killing it. The light alone would damage the virus but the photon lending substance allows the light to enter the virus directly killing it. This is simply a form of energy medicine, no different than cold packs placed on an injured ankle. The cold helps the pain and swelling. (“Energy medicine”)

  • Published clinical trials have proven the following; (www.imulux.com/news.html)
  • Patients consistently report immediate relief of outbreak symptoms following the Imulux protocol
  • Doctors and clinicians report expedited healing readily observable at 24 hour follow up of the Imulux protocol
  • Interviews with clinical investigators that have done 3 year follow up surveys showed the following facts:
  • 93% of patients contacted showed continued permanent remission (outbreak free) at three years following the Imulux protocol with one treatment.
  • with two treatments the percentage jumps to over 96%
  • 5 patients required 3 treatments for permanent remission
  • Only three patients required more than 3 treatments for permanent remission
  • Only one patient reported a total of 7 treatments for permanent remission

The following should be clearly noted here:

1) That many of the multiple treatment patients had more than one partner during this three year period and some admitted having multiple relationships prior to the administration of the Imulux protocol; thus it is possible for some individuals to harbor more than one strain of the herpes virus.

2) The Imulux protocol treats the current strain involved in the current outbreak only. After the Imulux protocol the individual will produce antibodies to the strain that is active in the current outbreak. These antibodies will not protect you from another strain. One successful treatment does not make it impossible for an individual to be re-infected with another strain of the herpes virus.

Most Common Reasons Why Imulux May Appear Not To Work for Some Patients:

1) Treating outside the window of an active outbreak (typically a four day window is all you have): An ACTIVE outbreak must be present for application to occur. It is imperative that the active outbreak is there. If you do not have an active outbreak when treating yourself, it may not work. DO NOT TREAT what may NOT be an outbreak, or DO NOT TREAT a premature outbreak, or DO NOT TREAT a post outbreak, BUT RATHER TREAT a real ACTIVE outbreak that is present.

2) Infected with Multiple Strains: If you have multiple strains, YOU WILL HAVE another outbreak. It is imperative that you treat the second outbreak with the appropriate Medpak. There are 8 different major categories of the herpes virus, and there are multiple sub-strains in each category, thus it is possible that you could have dozens of different strains in your body. Therefore it is possible that you may need to treat yourself multiple times. However, according to studies 93% of the people only have one strain, an additional 6% of the people have 2 strains, and less than 1% have more than 2 strains. YOU MUST TREAT EACH STRAIN SEPERATLEY WITH EACH OUTBREAK.

3) Multiple Partners: If you have multiple partners, YOU MAY CATCH another strain, and therefore you MUST treat the new strain separately. After the use of the IMULUX treatment on a particular strain, you are still susceptible to re-infection with a new strain.

4) Improper Application: You MUST apply the protocol correctly. And must see all the complete stages occur (i.e. “The florescence”). Without the florescence the virus is not present, and therefore too late or too early for the application of the protocol to be successful.

The Imulux Wellness Program allows you to receive FREE OF CHARGE additional Medpaks due to the above treatment failures.

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