News (Updated
June 20, 2010)
[Home]
[Previous
news]
June 18, 2010
(Discover) When it
comes to research on HIV and AIDS treatments, it can be hard to know when to
celebrate a small advance-everyone wants to see progress, but so many
experimental avenues that seemed promising have turned out to be dead ends.
Still, a new study that tried a sophisticated form of gene therapy as an HIV
treatment seems cause for cautious optimism. If it bears out under further
testing, the technique could lead to a one-shot, long-lasting treatment that
could replace the punishing regimen of daily medications.
Treating HIV currently comes down to controlling the viral load with a mixture
antiretroviral drugs, but over time, this drug cocktail becomes less effective.
Researcher John Rossi and his colleagues tried to craft a more permanent
treatment by genetically modifying the HIV-infected patients’ own blood stem
cells and increasing the cells’ ability to fight off the virus. The
researchers weren’t able to truly combat the virus in this experiment-the
patients’ viral loads remained the same-but their work moved beyond previous
attempts in two ways: They successfully modified blood stem cells by giving them
anti-HIV genes, and those cells survived for two years in patients.
According to ScienceNow: Earlier clinical studies the group conducted with the
same strategy made little headway, but now the researchers have overcome two key
obstacles, says Rossi, a molecular geneticist. One is that they managed to
stitch the anti-HIV genes into a high percentage of the appropriate stem cells.
The other is that the cells lived for a long time. “If we could increase the
number of modified cells by 10- or 100-fold, we might be able to stop the virus
itself,” says Rossi.
The small study published in Science Translational Medicine tested the safety of
the technique for HIV-infected patients, and served as a proof of concept. The
four patients in this study were undergoing therapy for AIDS-related lymphoma at
City of
"They modified the cells in three ways: They boarded up the cells’ doors
to keep the HIV virus out, and made two genetic changes to the cells’ internal
defenses so that the virus would have a harder time copying itself if it made it
through," according to ScienceNow.
As a safety precaution, the researchers didn’t implant enough of these novel
cells to test how well they might fight the virus, but they did get a glimpse of
how long the modified cells could stay in a person’s system. Up to two years
after the treatment, patients still had low levels of these special cells.
“That’s a major finding,” Rossi added. While the number of cells
expressing those genes was too low to provide any therapeutic benefit, it’s
“proof of principle” that gene therapy may provide long-term HIV treatment,
he said.
As a next step, researchers hope to implant a greater number of modified cells
in patients, to see how well they can fight and how long their defenses hold.
Emma Hitt, PhD
June 17, 2010 —
Nurse-managed care of patients receiving antiretroviral therapy (ART) for HIV
may result in comparable outcomes to physician-managed care and enable expanded
access to care in resource-poor settings.
Ian Sanne, MD, from the
University of the Witwatersrand, in
According to Dr. Sanne and
colleagues, a shortage of 4.3 million health workers (ie, physicians, midwives,
nurses, and support workers) exists worldwide, and only 17.4 medical
practitioners, most located in urban areas, are available to treat 100,000
people in
To compare outcomes of
nurse vs physician management of physician-initiated ART care for HIV-infected
patients, researchers randomly assigned HIV-positive individuals with a CD4 cell
count of fewer than 350 cells per microliter or World Health Organization (WHO)
stage 3 or 4 disease to ART care monitored by either nurses (n = 404) or
physicians (n = 408).
Treatment failure was
defined as a composite of the following endpoints: traditional virological
failure, occurrence of dose-limiting toxic effects, death, and all clinic losses
that translated to failure of the treatment strategy to maintain patients on
ART.
Of the patients, 46%
demonstrated treatment failure — 48% in the nurse group and 44% in the
physician group (hazard ratio, 1.09; 95% confidence interval, 0.89 - 1.33),
which was within the limits for noninferiority.
Other outcomes at a median
follow-up of 120 weeks were also comparable between the nurse- and
physician-monitored patients, including deaths (10 vs 11), virological failures
(44 vs 39), toxicity failures (68 vs 66), and program losses (70 vs 63).
According to the
researchers, approximately 16% to 17% of patients were considered treatment
failures because of the dose-limiting toxic effects of stavudine, which included
a high frequency of lipomorphological changes and lactate increases.
"WHO and South
African guidelines have moved away from reliance on stavudine; however, this
drug remains widely used in resource-poor HIV therapy programmes," they
write. "The dose reduction of stavudine to 30 mg after the first year of
the study, which was in line with WHO recommendations, might have reduced
drug-limiting toxic effects," they add.
“The results of this
study lend support to the expanded access to treatment with use of models of
task shifting in primary health care," the authors conclude.
Independent commentators
Mark Boyd, MD, from National Centre in HIV Epidemiology and Clinical Research
and St Vincent’s Hospital, , Sydney, Australia, and Chidi Nwizu, MBBS, from
the University of Maryland School of Medicine, in Baltimore, point out that
"it is marvellous to see the results of a practical and innovative study
which helps propel the field forward and improves our collective confidence that
despite all the obstacles we can succeed."
However, they add that
many HIV-infected patients reside and access care in rural areas. "The
study sites in [the Comprehensive International Program for Research in AIDS in
The study was supported by
the National Institutes of Health, the US Agency for International Development,
and the National Institute of Allergy and Infectious Diseases. The authors and
Dr. Nwizu have disclosed no relevant financial relationships. Dr. Boyd serves on
an HIV advisory board for MSD Australia and for Bristol-Myers Squibb Australia;
has received funding and/or has partnered with Merck, Abbott, and the American
Foundation for AIDS Research; and has spoken at events for Abbott and Merck,
received honoraria from MSD Australia and Janssen-Cilaq Australia, and serves as
vice president of the Australasian Society for HIV Medicine.
Lancet. Published online
June 16, 2010.
Early detection hope of
S.D. researchers
By Keith Darcé,
UNION-TRIBUNE STAFF WRITER
Tuesday, June 15, 2010
Earnie Grafton /
UNION-TRIBUNE
Dr. Sheldon Morris of
UCSD’s
BY THE NUMBERS
1.1 million: People living
with HIV in the
232,344: Estimated number
of Americans infected with HIV who don’t know it.
3,847: People in
56,300: Americans who
become infected with HIV each year.
14,000: Americans who die
of AIDS each year.
46 percent: Portion of
people with HIV who are black.
18 percent: Portion of
people with HIV who are Latino.
Sources: Centers for
Disease Control and Prevention;
The evolution of AIDS from
a deadly disease shrouded in fear to a largely manageable condition took another
step forward Monday, when
The report’s authors
said a rarely used blood test can spot HIV weeks before the body recognizes the
infection. They recommended that it be offered along with the more common
screening method to people at high risk of contracting the virus, including gay
men, intravenous drug users and people with multiple sex partners.
Among the 3,151
participants in a two-year study, the blood test identified HIV in 15
individuals who had falsely tested negative with the traditional saliva swab
procedure.
False negative results
occur in as much as 1 percent of those who take the swab test, which pinpoints
antibodies produced by the immune system in response to infection. It can take
as long as three months for the body to begin producing enough antibodies to
trigger a positive reading.
During that lag time,
people can unknowingly spread HIV through unsafe sex and miss early treatments
that could improve their health in the long run, said Dr. Sheldon Morris, an
AIDS researcher at the
Morris was lead author of
the HIV-testing report, which appeared Monday in the journal Annals of Internal
Medicine. His colleagues included other researchers from UCSD and
“If people got an
antibody test alone and were told they weren’t infected when they were, they
could be a strong infection risk until they get tested again, which according to
guidelines could be six to 12 months later,” Morris said.
The latest findings
reinforce similar conclusions from a 2005 study led by scientists at the
Participants in the
Morris said the pattern
demonstrates a shift in attitudes about AIDS. The illness once was viewed as a
death sentence that needed in-person counseling to deal with issues such as
shame and secrecy. But advances in detection and treatment have turned it into a
chronic, controllable condition for most patients — not unlike diabetes.
“HIV is not as
mysterious as it once was,” Morris said.
The early-detection blood
test, which homes in on nucleic acid RNA molecules produced by the virus, has
been used to screen most of the nation’s blood donation supply since 2002,
according to its maker, Gen-Probe of
The FDA approved the test
for use as an HIV diagnostic tool in late 2006, but its cost — as high as $100
— and more complicated administration have helped discourage widespread use,
said Rowena Johnston, vice president and research director of the New York-based
international HIV/AIDS research foundation known as AMFAR.
Samples for the blood test
are obtained through finger pricks and must be sent to a laboratory, which can
take up to two weeks to return results.
“The reason the antibody
test is (widely) used is because of low cost and convenience,”
But identifying people
with HIV within a few days or weeks of infection has become a public health
imperative, in part because the virus level tends to be highest during the early
infection stage — making transmission to others more likely, she said.
“This really is a key to
preventing HIV transmission,”
Because of the blood
test’s cost, health experts said, it probably isn’t practical to offer the
higher-level screening to the general population. It makes more sense to focus
on high-risk HIV groups because they record larger numbers of false-negative
antibody test results.
In the
Each participant was given
the saliva swab test, and then blood samples were taken from those who tested
negative. The samples were sent to labs in
Morris said the blood test
is sensitive enough to detect the virus components within 10 days of infection.
“I think the time is
coming where we will have to adopt a strategy for earlier (HIV) detection,” he
said. “If you have a testing site with a high-risk prevalence, then you
probably should be running this test on all of their samples” that tested
negative for virus antibodies.
Keith Darcé: (619)
293-1020; keith.darce@uniontrib.com
Regulators say his clinic
submitted phony data, forms with forged signatures
June 14, 2010|By Patricia
Callahan, Tribune reporter
In a rare move, federal
regulators are seeking to disqualify a prominent Chicago HIV doctor from future
drug studies after they discovered his clinic committed one of the most grievous
sins of medical research: submitting fictitious data in a drug trial.
The Food and Drug
Administration said Dr. Daniel Berger "failed to protect the rights, safety
and welfare" of patients under his care.
Doctors' and patients'
signatures were forged, even on forms where patients said they understood the
risks of the trial and those where doctors said the patients weren't too sick to
enroll, the FDA found.