Microbicide News
Fall-Winter News
GLOBAL:
"Group to Test Merck AIDS Drug in Gel"
Reuters , (03.11.2008) Maggie Fox
On Tuesday, the International Partnership for Microbicides (IPM) announced it
has received permission to use Merck and Co.’s experimental HIV drug L’644 in
testing as a potential vaginal microbicide. L’644 is a gp41 inhibitor that would
block HIV from attaching to immune cells.
“It’s a completely different mechanism of action to what we have currently under
development and what the field has under development,” said Dr. Zeda Rosenberg,
IPM’s CEO. “It’s pretty early in the life cycle for HIV. Most of us feel that,
for a microbicide to be really effective, it has to get at the infection in its
earliest time points.”
While condoms can protect men and women, in many countries a woman who insists
on condom use can face rejection or violence. In contrast, a woman could take it
upon herself to use a microbicide gel or cream to prevent HIV infection. In
sub-Saharan Africa, about 61 percent of adults with HIV are women, according to
UNAIDS.
“L’644 is a peptide that would need to be injected to act as an effective
antiviral,” said Dr. Daria Hazuda, vice president of scientific affairs for
infectious disease at Merck Research Laboratories. “As such, it was not deemed
to have a favorable profile for patient convenience.” Merck, therefore, is not
developing L’644 as a drug to treat HIV.
IPM has agreements with other drug firms to develop microbicides, said
Rosenberg. Other microbicide candidates include Merck’s L’167/CMPD167 compound,
a CCR5 blocker; Pfizer’s CCR5 inhibitor maraviroc; Gilead Sciences’ tenofovir,
in collaboration with Bristol-Myers Squibb; and Johnson & Johnson’s Tibotec
Pharmaceutical’s dapivirine.
Microbicidal Gel Shown to Be Safe in
HIV-Uninfected Women
AIDSInfo At-A-Glance Volume 4 Issue 11 (3/7/08)
Researchers in the United States and India
have determined that a tenofovir-based
microbicidal gel is safe for HIV-uninfected
women to use daily to prevent transmission of
HIV.
The 6-month study, conducted by the NIH's
Microbicide Trials Network, included 200 women
from India and the United States. There were no
differences seen in adverse events between women
using the tenofovir-based gel compared to women
using a placebo. Adherence was approximately 80%
and none of the women in the study became
infected with HIV while using the tenofovir-based
gel.
More information is available:
Group Releases Report on Rectal Microbicides
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=50738
Microbicides 2008 news reports
summaries from aidsmap news
(3/6/08)Microbicides 2008: Third-generation microbicides might
act as ‘bacterial vaccine’
Studies are underway of genetically engineering
naturally-occurring vaginal bacteria to produce microbicides
against HIV, and in one case such a strategy has already
proved effective in preventing HIV infection in monkeys, the
Microbicides 2008 Conference heard last week in Delhi.
Read More >>
Microbicides 2008: Will adherence issues affect all
the first-generation trials?
There are still two ongoing trials of the ‘first
generation’ non-ARV-based microbicide candidates ongoing,
and at the Microbicides 2008 Conference last week Sharon
Hillier, Principal Investigator of the Microbicides Trial
Network (MTN) gave delegates an update of data from these
studies.
Read More >>
Microbicides 2008: Cellulose sulphate has unexpected
tissue toxicity
Investigations into the candidate microbicide cellulose
sulphate (Ushercell) using the substance on vaginal
tissue samples have revealed that it causes loss of tissue
integrity by destroying proteins that bind cells together.
This allows HIV to leak into the underlying tissues.
Read More >>
Microbicides 2008: Microbicides might benefit men more
than women
An antiretroviral-containing microbicide could have some
very paradoxical effects, according to epidemiologist Sally
Blower, speaking at the Microbicides 2008 conference last
week in Delhi.
Read More >>
Microbicides 2008: the second generation is on its way
The next generation of microbicides designed to protect
women against HIV infection will rely on maintaining a high
level of an antiretroviral drug in the genital fluids and
tissue rather than using a barrier gel, Sharon Hillier,
Principal Investigator of the Microbicides Trials Network,
told the Microbicides 2008 conference this week in Delhi.
Read More >>
Microbicides 2008: Accurate adherence reporting
essential for microbicide trials
Researchers need much better ways of determining
adherence to candidate microbicides in trials, and also of
ways of determining sexual behaviour, the 2008 Microbicides
Conference heard today in Delhi, India.
Read More >>
Microbicides 2008: First hint of efficacy in rectal
microbicide trial, thanks to new biopsy assay
Preliminary, still blinded data presented to the 2008
Microbicides Conference in Delhi today offered a strong hint
that a rectal microbicide gel containing a non-nucleoside
HIV drug may prove to be effective at stopping infection in
humans.
Read More >>
Experimental Microbicide Tenofovir Safe for Women To Use Daily, Study Finds
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=50597
UNITED STATES; INDIA:
"Tests of New AIDS Gel Show Promise for Women"
Reuters , (02.25.2008)
An experimental vaginal microbicide gel containing the AIDS drug tenofovir has
proven safe and acceptable to women in Phase II trials, researchers told the
Microbicides 2008 Conference in New Delhi on Monday.
Funded by the National Institutes of Health, the study involved 200 sexually
active HIV-negative women in the United States and India. The study was designed
to evaluate the gel’s safety, not its efficacy.
“The gel is safe to use and well-tolerated by HIV-negative women,” said Dr.
Craig Hoesley of the University of Alabama-Birmingham. “This sets the stage for
larger studies to see if tenofovir can prevent HIV infection.”
It is still uncertain how long tenofovir can stay active after it is applied as
a vaginal microbicide, said lead investigator Sharon Hillier of the University
of Pittsburgh School of Medicine. “Currently, there are very encouraging studies
suggesting that even when tenofovir is gone from the vagina, the drug itself is
there in the vaginal tissue,” she said.
“The important thing we learned is that covert use, or secret use, is not an
important parameter for women, and that in fact we found that 12 percent of the
women who used the gel said it made sex more pleasurable and none of the women
said that the gel made sex less pleasurable,” said Hillier.
Among participants using the gel, 80 percent followed the experimental regimen.
“We asked women ‘How acceptable is this as a prevention option, is it too messy,
is it a nuisance, and will you use it?’” Hoesley said. “Our study showed they
will use it and they’re not bothered by the gel.”
“It is a critical time for all of us engaged in HIV prevention, and I truly
believe we are turning a corner,” Hillier said.
Experimental Microbicide Carraguard Does Not Provide Protection Against HIV,
Study Finds
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=50494
Pfizer To License Antiretroviral To IPM for Reformulation as Microbicide
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=50103
Mozambique Launches Initiative To Conduct Microbicide Research
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=49509
HIV Working Group Releases Report on Vaccine, Microbicide Research,
Development
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=49219
VIRGINIA:
"Eastern Virginia Medical School Awarded $28.5 Million
for AIDS Prevention Project"
Virginian-Pilot (Norfolk), (12.01.2007) Nancy Young
CONRAD, an Eastern Virginia Medical School (EVMS) program, has received a $28.5
million grant from the Bill & Melinda Gates Foundation to further its research
into developing a microbicide gel to thwart HIV infection, school officials
announced Friday.
Henry Gabelnick, the program's executive director, said a preventative topical
gel is key since women are especially vulnerable to HIV through sexual activity.
"It's clear that women are the majority of the new cases of HIV-positive
people," he said. "If their partners won't use condoms, this gives women a
product that they can use to protect themselves."
The five-year grant will go toward the development of microbicides that use
antiretrovirals to interfere with HIV's replication, said Dr. Gustavo Doncel,
director of preclinical research for CONRAD and an OB/GYN professor at EVMS.
"We're poised to deliver something that is significant in the area of HIV
prevention," said Doncel.
While there are no microbicides currently on the market, some have made it to
later stages of clinical trials. Developing one that is effective against HIV
has been difficult, Doncel conceded. "The virus is much sneakier and cheekier
than what we thought it would be," he said.
Gates Foundation Gives Group $28.5M for Microbicide Research, Officials Say
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=49188
Starpharma, SSL International To Produce Condoms With Microbicide VivaGel
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=48240
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