Peter Schick Newsletter - Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: A prospective cohort analysis. May 27 2010

Donnell, et al. Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: A prospective cohort analysis. Lancet 2010 May 27 2010

HIV Treatment doubles as prevention in Heterosexual couples. Antiretroviral therapy reduce the likelihood of HIV transmission by 92 % among heterosexual discordant couples in Africa. It is well known that providing antiretroviral therapy in HIV-infected individuals reduces the likelihood of HIV transmission, but how strong is the effect with serodiscordant couples, one HIV+and one HIV-. How should antiretroviral therapy be provided to maximize the benefit. A post hoc analysis from the Partners in Prevention HSV/HIV transmission study provides answers.

The study involved 3381 heterosexual serodiscordant couples in Africa. researchers compared transmission rates between the 349 HIV-infected individuals who initiated ART during follow up-(mostly because of pregnancy or low CD4-cell counts_ and the3032 who did not. Of those who initiated ART, 70% achieved viral loads below 2.4 log copies/nk. All study participants were counseled frequently about side effects, safe sex; unprotected sex was reported in only 7& of all follow--up visits.

A total of l03 genetically linked transmission events occurred, but one one was in a couple in which the infected partners was receiving ART. The transmission rate was ..37 per l00 person-years among individuals who initiated.

Among individuals who were not receiving ART, the rate of transmission was highest for those with CD4 counts less than 200: for those with CD4 cell counts greater than 200 cell/mm3, the rate of transmission was highest for those with viral load greater than 50,000 copies/ml.

This study clearly demonstrates that the risk for HIV transmission is highest among individuals with CD4 counts less than 200. Bit it also identifies another high-risk group: patients with CD4 counts greater than 300 who have viral loads greater than 50,000 copiesl/ml.

With the data now showing that ABC for prevention, abstinence, be true to your partner has failed, as has microbicides, vaccines, circumcision. treated infected people with antiretroviral therapy is the best way of preventing HIV infection in discordant couples. This will most likely remain than way until a vaccine is found.

OVER 19 MILLION WOMEN ARE LIVING WITH HIV/AIDS

OVER 19 MILLION WOMEN ARE LIVING WITH HIV/AIDS - TAKE ACTION STOP THE VIRUS

Donate to The Peter Schick Foundation non-profit organization committed to maintaining quality of life. www.schickfoundation.org www.schickresearch.com

Commentary

Heterosexual woman are the group of people most affected and infected with HIV/AIDS throughout the world. It is time to recognize women as the group that have been most affected by the virus. Women do worse with the virus, have more emotional problems in dealing with the virus, and more poorly tolerate the treatment of the virus. It is time that women who have the virus get the same benefits that men have who are infected with the virus. STOP THE VIRUS IN WOMEN is the most newsworthy comment for the month of JUNE.

Commentary of Peter Schick, Chairman of the Board of the Peter Schick Foundation

Commentary of Peter Schick, Chairman of the Board of the Peter Schick Foundation

I have been involved in this foundation for over 7 years. I have witnessed many claims for the eradication of the HIV virus. But until now, I have only seen antiretroviral drugs, immunotherapy, aborted vaccine trials both preventative and therapeutic. All of these have failed because until recently there has been a lack of knowledge of the pathogenesis of HIV infection. Now there is coming a new era of understanding what has to be done based on basic research. I believe, HIV infection will be solved by a biomedical solution.

The HIV virus,results in an infection which leads to immune dysfunction through CD 4+ T-cell depletion. The total CD 4 pool is involved and perhaps 60-70% of the CD 4 + pool lies in the GI tract, or gut. CD 4% is the best marker of CD 4+ depletion. The result of this virus entry into the body through microbial translocation is a severe immune activation. This can be measured in serveral ways. Without complex testing the best marker of the activation is the CD 38 cell surface marker. Immune activation in HIV infection includes 2 components. (1) the homeostatic response to CD 4+ depletions and an inflammatory component to the process which leads to the increased risk of morbidity and mortality from a variety of non opportunistic serious conditions. It has become increasing clear that inflammation contributes to this increased risk. Good markers of this inflammation are C-reactive protein, and D-dimer. Patients with higher levels of these markers do worse.

What might be the solution to the HIV problem. Certainly antiretroviral drugs to eliminate as much of the virus as possible, and slow down the immune activation. But studies have shown, that antiretroviral drugs will not stop the immune activation even with undetectable levels of the virus. So there must be something else to add or change if one hopes to eradicate the virus. It could be a type of gene therapy, or it could be a supplement, something added to the antiretroviral treatment, that focuses on diminishing the immune activation and the inflammation. We are studying a supplement that in pilot studies does just that. It slows down the immune activation and the inflammation caused by HIV.

That supplement is Blue green algae, or one of its family of algae, Spirulina. In a pilot study, Blue green algae, in a patient has caused the CD 4%, a very good marker of CD 4 pool together with an ARV, to rise from 25% to 35%, highly significant. An extract of Spirulina, has been found to kill 50% of HIV infected T cells in culture, the largest reservoir of HIV infection. We have received FDA approval thru a pre-IND application to study patients suppressed with antiretroviral treatment taking also the oral supplement Bue green algae, a bone marrow stem cell stimulator and antinflammatory agent acting thru suppressing the cytokine system. We are also planning on applying for an IND# for Spirulina, an extract of this kills in tissue culture 50% of HIV infected T cells. These clinical trials could open up the clinical trial field, a field that has been dormant in my mind for some time.

If you want to participate in this ground breaking, cutting edge research, you can learn more about our approach by viewing our web sites, http://www.schickfoundation.org/ or http://www.schickresearch.com/. While you are reading and if you are interested in being part of the solution, then donate on line to these ground breaking studies, or contribute to our foundation headquarters at The Peter Schick Foundation, 1223 Wilshire Blvd #1007, Santa Monica California 90203. Its time a solution is found, and the virus is eradicated.

Pre-IND approval from the FDA to study blue Green algae in HIV+virologically suppressed patients. (Continued)

The Peter Schick Foundation is looking to partner with Pharmaceutical Companies in their granting and and Charity Donations

Since our FDA approval for studying Type 2 Diabetes, and our PRE-IND # application approval by the FDA, and the pending final approval for our HIV+patients being treated with Blue green algae,we have sought to partner with the PhARMS for both Type 2 Diabetes and HIV/AIDS treatments. We feel that we are a natural partner for these companies, because Blue green algae is not toxic compared to many of these companies products, might prevent side effects of the treatment of these 2 states, and has a real chance of changing the course of both these horrible diseases, both in terms of morbidity to the patients, costs to medical providers, patients, families of patients, all of which are in the best interest of both organizations, the Pharma companies, and our Foundation.

We believe without question, that we are on the forefront, the cutting edge of treatment of both of these disease states. Both thru our foundation, which will do the clinical trials and report the results, and thru our new for profit company, an LLC, we are on the brink of having a very prosperous biotech company. Since linking and partnership are the basis of all bench mark research and clinical trials, we invite you as individuals, groups,and organizations, to partner with the Peter Schick Foundation. We are not soliciting donations, but of course we wouldn't refuse them.

But we are more interested in forming a health care consortium to deal with these horrible diseases. Whether it is by volunteerism, or by personal experience, share with us your stories, your problems, and although we might not be able to solve them, we will certainly listen. Do not hesitate to call us at 1-310-394-7989 or email us at schickpm@aol.com. Join the fight as we are doing, to right the wrongs of individuals affected with these horrible diseases, and let our organization give comfort to all of the people out there who seek it.

Have a great Spring

Peter Schick

Chairman of the Board of the Peter Schick Foundation

The Peter Schick Foundation has received a Pre-IND approval from the FDA to study blue Green algae in HIV+virologically suppressed patients.

Pre-IND approval from the FDA to study blue Green algae in HIV+virologically suppressed patients.

This is the first stage in what will be a very short time when a Permanent IND# is received from the FDA to study Blue green algae in HIV+virologically suppressed patients.

There is more and more evidence that 1 or 2 or 3 antiretrovial drugs will not cure HIV infection. That is because the antiretroviral drugs do not stop immune activation caused by HIV infection. What is going to be needed is either gene therapy or antiretroviral drugs plus a supplement like stem cells. Blue green algae is the only oral supplement that releases adult bone marrow stem cells into the circulation by 20-30% after oral ingestion. The increased number of circulating stem cells plus the effect of the cytokine suppressant activity of the algae might be enough to eradicate the virus when coupled with an antiretroviral drug; The algae blocks the uptake of the virus in the gut, increases the life span of memory T-cells, the main reservoir of HIV, and is the most powerful immune enhancer in the body. Stem cells direct the NK cells and also cellular and humoral immunity. We have a phase 2 study ready for implementation and a medical group that wants to do the study with us. Following the markers of immune activation, like D-Dimer, CRP, LPS, viral load and CD cell parameters, plus maybe the most important marker of immune activation, pro-viral DNA, will determine the success or failure of the study.

The Peter Schick Foundation has developed a protocol for LDL cholesterol.

In a pilot study of an HIV infected patient, the data showed a 50% reduction in LDL cholesterol in this patient after 6 months of treatment with blue green algae. The patient did not have abnormally high LDL levels from the start.The foundation is interested in studying LDL cholesterol. A protocol ha been developed to study Blue Algae in people who have an elevated LDL cholesterol. We are looking for a 30 to 40% reduction in LDL cholesterol as significant. Since there are no side effects to Blue green algae, this could lead to the elimination of a lot of anti lipid lowering pharmaceutical drugs. Blue green algae is cheaper, and has fewer side effects than the pharmaceutical drugs available for lowering LDL cholesterol. This protocol fits very well into an already finished protocol dealing with post-coronary bypass patients in rehabilitation. LDL cholesterol is the major contributor to heart disease and stroke. The protocol when implemented should be completed in 6 months.

Two new additions to the Peter Schick Foundation personnel

Two new people will shortly be joining the Peter Schick Foundation. Dr. Michael Hamrell, who has worked as a regulator at the FDA, and both a regulator and a researcher at the NIH, will join the foundation. He will be the director of Basic benchmark research, something he has done in the past. He will also help in the writing and devising of new protocols for the foundation, and will assist the foundation in getting its protocols thru the FDA, as he does in his consulting firm which he runs. Cindy Sopko CPA and life coach will be joining the foundation shortly in a part time position. She will participate in the final stages of the business plan which already has been developed by Michael Fidler and Peter Schick. She will also take part in presentations made to key personnel both in the scientific and fundraising arena. Cindy is an excellent writer and will also participate in newsletters, and messages posted on our web sites.

To see these 2 very important protocols implemented and completed we ask for a donation from you. You can say that you made a difference in some of the major diseases of our time.

To donate you can send a check or money order to The Peter Schick Foundation, 1223 Wilshire Blvd, #1007, Santa Monica California, 90403. Or you can donate on line on either of our two web sites www.schickfoundation.org, or www.schickresearch.com.

This session of the CROI meeting was entitled Progression of Arteriosclerosis: role of inflammation and T Cell Activation

This session of the CROI meeting was entitled Progression of Arteriosclerosis: role of inflammation and T Cell Activation

It is now becoming clear that the progression of Cardiovascular disease is associated with HIV infection. In fact arteriosclerosis, heart disease, and stroke may contribute more to mortality and death than immune suppression leading to AIDS. A person who is HIV+ who is treated earlier and maintains viral suppression for 2 years can have the same life expectancy as an HIV- person of the same age. Now it is time to work on some of the co-morbidities associated with HIV infection such as Heart disease.

The first paper demonstrated that earlier initiation of antireroviral therapy is associated with decreased vessel stiffness. Viral stiffness and subsequent clots and endothelial swelling of the arteries are associated with cardiovascular events. So the point of the study is to start treatment of HIV infection earlier to stop the process that is causing increased cardiovascular disease.

The second paper talked about the inflammation that is present in the arteries which causes endothelial swelling and subsequent cardiovascular problems. Again the object is to stop the inflammation, Antiretroviral therapy starting early can decrease the inflammation, caused by untreated HIV infection.

The third paper talked about T-cell activation and T-cell senescence in HIV infection. It is becoming apparent time and time in these sessions that the major marker to follow in HIV disease is not viral load or CD 4 count but activation of T cells. This can be measured by the markers of T cells, like CD 38 for activation and CD 28 for senescence. These are the markers that people should pay as much attention to as viral load and CD 4 count.

It is interesting that in vascular disease and cardiovascular events, blue green algae may prove to be of great benefit. Blue green algae has among its natural components L-selectin ligand, and phycocyanin. L-selectin Ligand releases adult bone marrow stem cells into the circulation, and stem cells are directed to the place of injury, in the above situation the vascular tree. In addition phycocynain, a chlorophyll agent is very anti inflammatory, and at the place of injury that HIV causes, like in the vascular tree, it cuts done on inflammation.

Blue green algae may find its greatest use in Cardiovascular disease caused by HIV, in decreasing the immune activation, the inflammation that is so prominent in all the manifestations of HIV disease, particularly cardiovascular disease, which is becoming the #1 killer of HIV+ patients.

The first session that I attended was entitled HIV Vaccines: The Path forward.

The first session that I attended was entitled HIV Vaccines: The Path forward.

This is an appropriate title for this session considering the beating that HIV vaccine researchers and vaccine planners have taken over the last 2 years. The Merck-Government (STEP) vaccine failed miserably. Why, poor planning, poor implementation, poor science, politicians involved in the trial, failure to study the behaviors of Africans, and finally the desire by the past American administration to solve the HIV/AIDS problems as a lasting legacy to George Bush. All of this failed. Dr. Anthony Fauci put a halt on all government sponsored Vaccine trials because of those failures and he recommended that we go back to the drawing board, to do basic research, to restudy the virus and the immune system. That is what Vaccine researchers are doing no with mixed success.

The first talk was given by Miller of the RV 144 vaccine update from the Thailand based vaccine trail of 2 different vaccine candidates used to vaccinate people at the same time,, the ALVACX and the AIDSVAC candidates. People were randomized to get either both of these candidate vaccines or none in the placebo arm. Thee was a large number of people that participated in Thailand, 26,700, and the trial was ;powered in the right way, but although it showed some efficacy briefly, most people would consider it a failure in protecting people from HIV.

There then was another talk analyzing the STEP vaccine trial and why people continue to analyze this failure is beyond me. This talk was a failure also.

There followed a talk on therapeutic vaccine by the ACTG termed ACTG 5197. Therapeutic vaccines are given to people who are already infected. The study showed a 1/4 log benefit in the therapeutic vaccine. Again one has to question why in this day and age of excellent antiretroivrial drugs why anyone would opt for this trial when they could opt for another antiretroviral drug if they were failing treatment.

An interesting talk followed on using dendrite cells as the vector for autologous HIV. Dendritic cells are an excellent cell in the body where the virus multiplies. So using dendrites as a vector for delivering the vaccine candidate is a good idea but again no positive results from this study.

Finally two late breading talks were given.The first used a pox-virus based HIV vaccine requiring 3 injections of this DNA vaccine. This was a phase 1 study to show safety first. Immunogenicity of this vaccine was increased with 3 injections of this DNA based vaccine. DNA vaccines are the hottest thing going to find a preventative vaccine for HIV. These people are on the right tract.

Finally there was a talk on GM-CSF for use as an adjuvant to a candidate vaccine. These also would be used with DNA as the vector. This study was done in macaque monkeys but it is something worth watching as the field of vaccinology proceeds.

All in all the data for a protective vaccine was pretty disappointing. I do not believe there will ever be a vaccine found for HIV, The virus mutates too much, there are two many different types of the HIV virus. We must look to other means of prevention.