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July 2010, Week 4

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Thu, 22 Jul 2010 21:50:35 -0400
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AFRICA 

Antiretroviral Gel Lowers HIV Infection and Offers Hope to 
Women

By Zahira Kharsany

July 21. 2010, Inter Press Service

http://ipsnews.net/news.asp?idnews=52231

JOHANNESBURG, Jul 21 (IPS) - When women from the
predominantly rural Vulindela district in KwaZulu-Natal first
began participating in an HIV-prevention trial many were
unable to negotiate the use of condoms or even discuss safe
sex with their partners.

But as they used the discreet antiretroviral (ARV)
microbicide gel, for the first time women - who bear the
brunt of the HIV epidemic in Africa - were in control of an
HIV-prevention method. And empowerment for almost 900 women
turned into hope for millions of women across Africa when the
study showed a 39 percent success rate in the prevention of
HIV and a 54 percent success rate in the prevention of
herpes.

The groundbreaking research, which was first to use the ARV
drug tenofovir as a gel, was released by the Centre for AIDS
Programme of Research in South Africa (CAPRISA) at the XVIII
International AIDS Conference in Vienna, Austria on Jul. 20.

"For me these women are champions for agreeing to use an
unknown product. It needs to be investigated further to
verify the results but the women are part of the break
through," said Mukelisiwe Mlotshwa, the research nurse and
team leader for clinical procedures of the CAPRISA 004
microbicide trial.

The research dealt with the safety and effectiveness of the
ARV microbicide gel and 889 randomly selection women
considered to be at high risk of HIV infection participated.
The study was conducted in the most affected HIV areas of
South Africa, both of which are in KwaZulu Natal: Vulindlela,
a rural area which has high rates of unemployment and a high
migrant population; and Durban, an urban area.

There were two groups, a placebo-controlled group and one
which received the tenofovir gel. Participants visited the
clinics monthly and were clinically examined for potential
side effects as well as being tested for HIV infection.

The study was also double-blinded, meaning that the
researcher as well as the participating women did not know
whether they were receiving the tenofovir gel or the placebo
gel.

Women were advised to use the gel up to 12 hours before sex
and soon after having sex with a maximum of two doses in 24
hours. Those participating used the gel for a minimum of one
year and a maximum of two and a half years.

Mlotshwa said the product played an important role in the
women’s lives. "Most of these women used to say that ‘this
product is so nice and so discreet’, so much so that their
partner never knew they were using it at all. They told us
that their partner could not feel anything as well."

Even though the gel is seen as a discreet substance, nearly
70 percent of the women participating in the trial did
disclose to their partners that they were using the
microbicide gel. Only six percent of the partners reported a
dislike for the women to use the gel.

Dr. Janet Frohlich, CAPRISA’s Vulindlela Clinical Research
Site Director, explained to IPS that microbicides are a type
of a gel substance which women can insert into the vagina or
rectum which "we hope to show with this trial can help in the
prevention of the spread of HIV."

The microbicide gel contains one percent tenofovir, a common
ARV drug used widely in the treatment of HIV.

If other studies prove the gel to be effective and confirm
the results, the use of the gel would become widespread and
offer women a higher level of protection, resulting in
preventing over half a million new HIV infections in South
Africa alone over the next decade estimate researchers.

Frohlich said that the research is a milestone as there are
eleven trials with six different kinds of microbicide
products, but this is the first trial of its kind to use
ARVs. "As we know ARVs can be used in the prevention of HIV,
and a gel can help in the prevention of transmission in
heterosexual couples," said Frohlich.

Women have never had the complete power to protect themselves
against HIV infection, till now. "Like Ghana was Africa’s
hope at the World Cup, this trial is for all of Africa. Women
across Africa and globally who are not able to negotiate
condom usage can now prevent HIV and herpes transmission on
their own. Women now have the control over their health and
well being," explained Frohlich.

Doctor Quarraisha Abdool Karim, Associate Director of
CAPRISA, study co-principal investigator and Associate
Professor of Epidemiology at Columbia University agreed.

"This new technology has the potential to alter the course of
the HIV epidemic, especially in southern Africa where young
women bear the brunt of this devastating disease," she said.

Empowerment

When the trial started women were counselled on risk
reduction and condom use, and the importance of building
relationships with their partners.

"We explained to the women that you cannot negotiate using a
condom in bed. It’s too late. It must be done before,"
Mlotshwa said.

"At the monthly check ups, you could see the women growing.
You can see them becoming empowered and confident in their
personal relationships."

The counselling during CAPRISA 004 trial was so successful
that morning health talks started for the women in the area.

"It was nice to see them growing in the study. They are now
sharing information on HIV prevention amongst themselves,"
Mlotshwa said.

The Next Step

"The study really needs to be confirmed," insists Frohlich.

"We need to look at the different dosages of tenofovir ARV in
the microbicide trail. This trial only used one percent of
tenofovir. We also need to look at different ARVs."

Frohlich said VOICE (Vaginal and oral intervention to curb
the epidemic) trial, which is part of a set of trials across
the globe, will help verify the CAPRISA 004 results. "The
VOICE trial is being conducted through the Microbicide Trails
Network, which a number of sites are conducting. The trial
uses two ARVs; one is tenofovir and the other truvada and
compares them to a placebo. CAPRISA is also participating and
this will help us judge the study and confirm results."

The CAPRISA 004 trial is funded by both the United States
government as well as the South African government though the
department of science and technology.

"Once the trial is confirmed, we will need to license the
product. Once this is done it needs to be made available to
women. But as an ARV product, women will need to come to
clinics every six months for checkups, like with any other
ARV treatments."

(END/2010)

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