Darin BrownMore clinical trials in Africa
Posted by Henry Bauer on 2009/07/31
“AIDS prevention trial in Zimbabwe targets women
Wed Jul 22, 2009 12:25pm EDT
…
About 5,000 sexually active women are expected to enrol at sites in Zimbabwe, South Africa, Uganda, Zambia and possibly Malawi as part of the study, conducted by the U.S-funded Microbicide Trials Network.
The study will determine whether some of the antiretroviral (ARV) medicines used to treat HIV can also be used to prevent the disease when given as a vaginal microbicide gel or as an oral tablet taken once daily.
In addition, the study, which will specifically test the ARV tablets tenofovir and Truvada, seeks to find out which of the two approaches women would prefer. Tenofovir was also the active ingredient in the vaginal gel.
‘We think its very unique because nobody has really tested the difference between an oral route of prevention compared to a vaginal route of prevention,’ Dr Mike Chirenje, protocol co-chair for the entire study, told Reuters on the sidelines of an AIDS conference. ‘Its not so much which was best, in so much as what would women prefer (to take),’ he said of a study expected to last three and a half years before first results in 2012.
Recent studies have shown that microbicides can protect women — who represent nearly 60 percent of adults living with HIV in the world’s worst affected sub-Saharan Africa region — from catching the virus.”
Those “recent studies” were not cited, however. For a summary of the failures of microbicide research, see “The Research Trough — where lack of progress brings more grants”, 10 September 2008. Less than a year ago, it had been noted that “two decades of studying microbicides that would block HIV and other sexually transmitted diseases” had led to “several promising candidates that interfere with the process that allows HIV to replicate” — which is far from preventing “infection” in the first place, which is what microbicides or vaccines are intended to do.
What to say about a trial that will feed antiretroviral drugs for 3½ years to 5000 women who are not even “infected”?
For tenofovir (TDF) it is known, for example, that “Renal impairment, manifested by increases in serum creatinine, glycosuria, hypophosphatemia, and acute tubular necrosis, has been reported . . . . In patients who have some degree of pre-existing renal insufficiency . . . tenofovir dosage adjustment is required. However, because no safety and efficacy data that use the dosage adjustment guidelines for renal dysfunction are available, the use of alternative NRTIs (especially abacavir) may be preferred over dose-adjusted tenofovir in this setting” [p. 33, NIH Treatment Guidelines, 3 November 2008]. In addition to renal damage, “adverse events” of TDF include “asthenia [loss of energy], headache, diarrhea, vomiting, flatulence, Fanconi syndrome [a specific form of renal dysfunction], osteopenia [bone loss not yet as severe as osteoporosis]”. Truvada combines TDF with FTC (emtricitabine) which adds the risk of skin discoloration (p. 131).
The popular paraphrase of the Hippocratic Oath, “First, do no harm”, would seem difficult to reconcile with feeding dangerous drugs to healthy human beings when the only conceivable purpose is to find a means of protection that might be an alternative to the entirely non-dangerous use of condoms — leaving aside the fact that there’s not even a sexually transmitted “HIV” to be protected against.
This entry was posted on 2009/07/31 at 10:36 am and is filed under antiretroviral drugs, clinical trials, HIV transmission, sexual transmission, vaccines. Tagged: antiretroviral drugs as microbicide, “side” effects of antiretroviral drugs, Emtricitabine, HIV microbicide trial, Mike Chirenje, prophylactic antiretroviral drugs, Tenofovir, toxicity of antiretroviral drugs, Truvada. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.
HIV/AIDS Skepticism 
Oigen said
Another African Guinea pig trial outrage..
Circumcision in HIV-infected men and its
effect on HIV transmission to female partners in Rakai, Uganda: a randomised
controlled trial……..
Were these women not told when signing up for this trial that they were risking exposure to the supposed viral killer of all time that contraction with, according to HIV mongers, will surely kill one? (HIV equals AIDS equals certain death) In practically any other part of the world deliberately exposing anyone with the HIV Godzilla resulting in infection and/or death lands one in court with charges of attempted or outright murder. But in Uganda, well I guess everyone is fair game for HIV sleuths.
Henry Bauer said
Oigen: The trial surely doesn’t involve deliberately exposing those women to “HIV”. The “basis” for it is the belief that Africans, and perhaps African women in particular, are at special risk for contracting “HIV”, because of the alleged African propensity for “multiple concurrent sexual relationships”. As James Chin, former epidemiologist for the World Health Organization has pointed out (“The AIDS Pandemic”), the African “epidemic” can be made to jibe with HIV/AIDS dogma of a sexually transmitted disease only if 20-40% of adults are continually engaged in sex with several partners at any given time, changing those partners every few weeks.
It is on that absurd and racist belief that all the “prevention” trials in Africa are based: it is assumed that among 5000 African women, within 3 1/2/ years UNDER NORMAL CIRCUMSTANCES AN APPRECIABLE NUMBER WOULD BECOME “INFECTED” WITH “HIV” — a sufficiently large number that some “prevention intervention technique” could potentially yield “statistically significant” results.
Sabine Kalitzkus said
Henry,
The Hippocratic Oath has been outdated for many years. According to the Declaration of Geneva doctors are allowed to do any harm to anybody – as long as they demonstrate unconditional obedience to their superiors. Obviously that’s a variant of the Commandment “Thou shalt honor thy parents no matter what they’ve done to you or to anybody else!”
And does not each and every package insert of each and every ARV tell us, that this drug X is neither able to prevent “HIV” infection nor to cure it? No matter on which route it enters the body?
As to African women I could imagine that they would certainly prefer to be approached with sufficient and tasty food and fresh and clean water instead of toxic ARVs.
Why don’t these US-American researchers with their extremely low male self-esteem and their female bunnies with corresponding disorders simply ask them?
Henry Bauer said
Sabine: If the researchers were to offer food to starving Africans, it might interfere with studies of whether antiretroviral drugs work better in people who are not malnourished [DRUGS OR FOOD?, 25 December 2007] or studies of whether “FOOD IS GOOD FOR CHILDREN”, 8 January 2008.
Onnie Mary Moyo Phuthe said
As to African women I could imagine that they would certainly prefer to be approached with sufficient and tasty food and fresh and clean water instead of toxic ARVs. This is how i am surviving, i am sure, its what every one needs for Africa to have its pride. we are hard workers, but th desert we live in does not support us to be the farmers we are. so funding in the direction of have a syndicate of boreholes shared by a few farmers would indeed yield more results, that would the costly arv would. this would even reduce th maternal deaths and death of the under 5 kids.
Then we would all be sure to have a healthy beautiful African women, who would not even have to have many partners. Did you know that from what i have learnt in our African society a man is a lover not because he is loved but because, he can provided financial security, for the women who are financially secure, will want a man who has a prestigious title in society. Love alone means nothing for women, if thy are in love and the children still go without food, the woman has to do something, and the easy way for women is to be promiscuous.
a relationship can be ended on the grounds that the man gives nothing, a a married man may be a preferred candidate because he will take his wife and his own earnings to support the girl in the armpits (that is what they call the secret girlfriend).
somof the reasons are that in Africa a girl child is married off for the benefit of the parents, depending on who the man is, if he has nothing, he gets nothing , if he has something even in an abusive relationship the parents will send the girl back to the man, because they can eat. women and girls situation is far worse. they must provide for their families. there are more std’s to worry about besides what thy are targeting HIV.
Sabine Kalitzkus said
Henry,
How could you recommend food for children??? Don’t you know how many vitamins there are in just ordinary food? That’s pure poison!
As we all know, kiddies put everything into their mouth; without any doubt they would even put plain food into their mouth. And you know what will happen then?! They will all die from swine flu! Thousands, tens of thousands, millions of them will die, just because you recommend to give them food.
Kiddies don’t even know how to wash their hands! I’m afraid you don’t know it either. Nobody does. That’s why thousands have already died from swine flu. I’m totally happy that now, after me having been living on this planet for many decades, finally somebody is courageous enough to tell me how to wash my hands.
Here’s how to do it:
http://www.who.int/gpsc/clean_hands_protection/en/index.html
Same organization (WHO) that has been telling us for decades, that breastfeeding means killing your baby, all of a sudden they changed dogma and are telling us the opposite now.
http://www.who.int/entity/mediacentre/news/statements/2009/world_breastfeeding_week_20090731/en/index.html
I don’t remember the name of the band and I don’t remember the name of the song, but it was a British band with a female singer with an extraordinary voice, who decades ago created a song about a puppet on a string.
And … yes … don’t know what to say … I’m speechless … one and a half years ago you published the second most important article on AIDS (Tony Lance’s Intestinal Dysbiosis; the most important being Casper Schmidt’s opus) … and now … you’re telling us that people who are NOT malnourished for whatever reason, those people should be so seriously ill that they even should swallow highly toxic ARVs.
I repeat: I’m speechless!
Henry Bauer said
Sabine:
“I repeat: I’m speechless!”
That’s just another of the direct, or perhaps “side” effects of “HIV”, “AIDS” and especially HIV/AIDS theory
mo79uk said
Tenofovir looks like it might exacerbate the vitamin D deficiency many Africans face with conservative sun campaigns going global — adequate sun exposure being as crucial as food and water.
And then the deficiency would be pinned as a progression of AIDS.
Tenofovir reduces cholesterol (the cholesterol con is something I won’t get into here), and cholesterol in the skin is turned into Vitamin D3 when hit by UVB.
I would hedge that with lowered total cholesterol, less is pushed into the skin also. And unlike statins there’s no other anti-inflammation mechanism to make up for it.