NHVMAS statement on CAPRISA 004

Hope on the horizon for HIV prevention in women using topical ARV gels

July 19th 2010, 900pm – The results of the CAPRISA 004 brings so much joy and hope for the many women and advocates in Nigeria and for us at the New HIV Vaccine and Microbicide Advocacy Society: a coalition that has invested years in working towards gingering public support for New HIV Prevention Technology Research and Development in Nigeria. The study showed the ARV containing microbicide gel was 39% effective in reducing a woman’s risk of becoming infected with HIV during sex and 51% effective in preventing genital herpes infections in the women participating in the trial.
The CAPRISA 004 study was conducted in Africa. It was a study of 1% tenofovir – an antiretroviral drug widely used in the treatment of HIV – put in a gel and applied in the vagina 12 hours before and 12 hours after sex. The gel was not expected to be used more than twice in 24 hours. The study recruited 889 women from South Africa. Overall, 98 women out of the 889 became HIV positive during the trial—with 38 in the tenofovir gel group and 60 in the placebo gel group. The study was conducted with high scientific and ethical integrity with evidence of extensive community and national stakeholders engagement and support.
While this study is only a proof of concept study (only shows that ARV based microbicides can indeed prevent sexual transmission of HIV infection), this scientific breakthrough gives us much hope about the VOICE study.
We congratulate the entire CAPRISA team, who worked so hard to make this grounbraking reasearch a success story. We equally appreciate the trial participants, communities, The South African Government and the many other stakeholders around the world for helping to see to the successful conclusion of this important trial.
NHVMAS looks forward to the results of the VOICE study that will tell us more about the efficacy of this ARV based microbicides. We also look forward to hearing about the much needed work with regulatory agencies, product manufacturers and all other stakeholders that need to be mobilised now so as to ensure this product is in the hands of people who most need it in the shortest possible time IF and WHEN the VOICE study confirms this wonderful result.

NHVMAS statement on MDP 301 result:

The result of the MDP 301 announced today was a disappointment for many of us in the New HIV Vaccine and Microbicide Advocacy Society: a coalition that has invested years in working towards gingering public support for New HIV Prevention Technology Research and Development in Nigeria. We had looked forward to the MDP 301 results hoping it will confirm speculations of an effective microbicide following the HPTN 035 results.

 

While the MDP 301 results do show conclusively that 0.5% Pro 2000 does not prevent HIV transmission through vaginal sex, this result have not in anyway diminished the need and importance of microbicide as a possible HIV prevention tool for sexual transmission of HIV infection: the very reason NHVMAS had worked to promote community support for biomedical HIV prevention research.

 

The MDP 301 study is the largest international clinical trial to date and it studied the effectiveness of a preventative HIV gel. Results show no evidence that the vaginal microbicide, PRO 2000, reduces the risk of HIV infection in women as announced by scientists today.

 

This placebo-controlled trial involved 9,385 women at six research centres in four African countries. The study found that the risk of HIV infection in women who were supplied with PRO 2000 gel was not significantly different than in women supplied with placebo gel. Although ineffective in providing protection, PRO 2000 gel itself was safe to use.

 

The report of the trial also shows that trial participants liked the gel and used the gel. Our studies in Nigeria also showed that women engaged in past CS3 and SAVVY trials like the gel. This points to the possibility of women using a gel as a microbicide WHEN a product is finally developed.

 

The results of the MDP 301 study does not reduce in anyway, the need for a product to prevent HIV infection either through anal or vaginal sex. Continuing research into developing a microbicide to be applied topically to prevent sexual transmission of HIV is needed. Development of a product that a woman can control, buy off the counter without prescription, and equally increases sexual pleasure should continue as a research global agenda.

 

We congratulate the MDP team for a successfully conducted trial. We equally appreciate the trial participants, communities and stakeholders in the various countries where these trials were conducted for helping to see to the successful conclusion of this important trial.

 

NHVMAS looks forward to the results of the CAPRISA 004 and the MTN 003 studies that will tell us more about the efficacy of ARV based microbicides. We also look forward to the conduct of future non ARV based microbicide studies while we globally push for universal access for existing and effective HIV prevention tools.

NHVMAS celebrates its 7th Anniversary with funfare!!!!

NHVMAS celebrated its 7th anniverary on the 4th of June 2010. The celebration also conincided with the opening of its secretariat office located at 51/52 Ijaye Road Ogba, Ikeja Lagos. The ceremony provided a platform to bring together friends and advocates of NHVMAS within and outside Lagos State. It also gave partners and friends an opportunity to familiarizethemselves with the vision and mission of the organisation.

NHVMAS was nurtured and hosted for the first seven years of its existence by Journalist Against AIDS (JAAIDS) Nigeria. This was because late Omolou Falobi was a co founding visioneer of the organisation.

The NHVMAS Co-Coordinator, Ms Olayide Akanni gave an account of the seven years of stewardship of the organisation and an assessment of the impact it has made in the field. These include:

l  Integration of NPT advocacy issues into ongoing HIV/AIDS activities

l  Increased community awareness about NPT research and development efforts

l  Increased national visibility of NPT issues in national discussions and HIV/AIDS programming

l  Increased capacity of national IRBs and relevant authorities to review NPT protocols and provide monitoring oversight

l  Development of a National Standard of Care document

l  Strengthened capacity of Nigerian NPT advocates and researchers.

l  Strengthened collaboration with policymakers and increased focus on NPTs within the national strategic framework

l   NHVMAS serving as a community watchdog

l  Dissemination of NPT clinical trial results

l  Increased collaboration with national, regional and international organizations

l  Facilitating information sharing between stakeholders

Goodwill messages received from friends and partners from far and near were shared.

A Brief History of New HIV Prevention Research

Early in the epidemic, it was well recognised that the best long-
term hopes for controlling AIDS is the development and widespread
distribution of a safe, effective and affordable vaccine, which
prevents primary infections. Over the last 10 years, funding for HIV
vaccine research has grown astronomically. The 2006 funding for AIDS vaccine development neared the US$1 billion mark, coming in at an estimated US$949 million. This figure reflects a 25 percent increase from 2005. The funders in the field have been The International AIDS Vaccine Initiative (IAVI), Bill & Melinda Gates Foundation, NIH, Europrise. Other players in the field include the Center for HIV- AIDS Vaccine Immunology (CHAVI) and the Gates-funded Collaboration for AIDS Vaccine Discovery (CAVD) which unite major players in the field with unique agreements on data- and sample-sharing, all with the goal of overcoming some of the toughest scientific challenges. For more about the HIV vaccine research field and community related work, visit www.avac.org and read the AVAC Report 2007: Re-Setting the Clock. In the HIV vaccine field there has been one completed phase III trial in Thailand. The product was found not to be able to provide enough protection from HIV infection. Recently, another HIV vaccine trial (Step and Phambili studies which were testing Merck’s candidate) was stopped because data from the studies were not showing any promises of the vaccine providing protection for trial participants. There are other HIV vaccine candidates been tested around the world including India, China and South Africa While there is advancement with HIV Vaccine research and development, there is also equal efforts at developing a safe,
effective and affordable microbicides which will allow women – who
most bear the brunt of the epidemic – power to protect themselves
from infection. There types of candidate microbicide that went
through phase III trials (trials that involve 1000s of persons to
test of the product or drug can do what it is expected to do when
used in conditions less than ideal) – Nonoxynol 9, SAVVY, Cellulose
sulphate – were not found to be effective. Results of the Carraguard
studies, another candidate microbicide that underwent phase III
trials in South Africa, would be out in February 2008. We still
await results of the Pro 2000 and Pro2000/Buffer gel studies. We
should hopefully have these by 2008. There are also a lot of new
studies at phase I (studies to show products are safe) and phase II
(studies to show products can do what they are meant to do under
ideal conditions). These new studies are evaluating antiretrovirals
as possible microbicides.

In an effort to ensure that HIV prevention is comprehensive (read
attached slides), many studies are been undertaken to develop more prevention strategies. These include:

• The possible use of antiretrovirals to prevent HIV infection. This
is known as HIV pre exposure prophylaxis. The concept is borrowed
from other pre-exposure prohylaxis like malaria and TB prophylaxis
where the same drugs used for treatment can be used to prevent
infection
• Adult male circumcision which three large scales studies have
shown to help reduce the incidence of HIV infection
• Cervical barriers. However recent studies using the diaphragm
shows that this does not reduce the risk for HIV infection
• Herpes Simplex virus infection treatment
• Evaluation of newer HIV treatment drugs so as to ensure effective
HIV infection management and reduce the rate of transmission of
infection. Currently, 3 new antiretrovirals have been approved for
use by the FDA in the USA.

Any questions?
Moderator

NHVMAS at ICASA 2008

On the 2nd of December 2008, SIDACTION organised a meeting of all its partners engaged in the field of HIV research ethics. Present were organisations from Cameroon, Burkina Faso (3), Cote D’Ivoire,
Republic of Benin, Senegal and Nigeria (2).

During the various presentations of group work and activities, it was
clear that there are some critical gaps in the field: Communities
were increasingly interested in the ethics of conduct of HIV
treatment (ARV and herbal) and prevention research. Yet capacity to
engage in the field was effectively lacking. Also, there was very
little engagement and training of the media in responsible reporting
about HIV (a medium that could be actively engage with research
literacy); and little or nothing was done in most countries on New
HIV Prevention technology issues.

Needs identiifed that should be addressed in the coming months
include:
– capacity building for organisations on ethics
– increasing networking so as to share best practices and lessons
– need to share materials – factsheet and training tools
– training of journalists
– addressing claims and researches on herbal cures for HIV infection
– need for community to serve as ‘monitors’ of clinical trials in the
field There was a consensus that the region needed to have a network for AIDS service organisations engaged with the ethics of HIV Research. NHVMAS volunteered to host this network and nurture its birth and evolution over the next one year

Morenike Ukpong

New HIV Prevention Technology research: the Nigeria story

Nigeria had in some good ways contributed to the global efforts on
New HIV prevention technology research.

1. Phase I CS3 study: Between the 16th of December 2001 and 4th July
2003, the Centre for Research and Reproductive Realth (CRRH),
Sagamu, Nigeria conducted a phase I (safety and acceptability) study on 6% cellulose sulphate trial as a possible microbicide product. This was part of a multicentre study involving 66 women aged 19 to44. the study noted that the product appear to be safe and well tolerated

2. Acceptability study of Nonoxynol 9: In the late `90s Nigeria,
through the University of Port Harcourt, was engaged in an
acceptability study of nonoxynol 9. The study evaluated the
acceptability of Nonoxynol 9 (N9) foam and film. The study was
aborted abruptly following the results of the UNAIDS multi-centre
effectiveness study that showed that N9 increased the risk of HIV
infection. The wealth of information from that data was not shared

3. Lime juice use as microbicide: A feasibility study on the
possible use of lime as a microbicide was conducted in Nigeria in
October 2003. an expanded study was planned following the outcome of
the Nigerian study. However, strong global evidence pointed to the
potential for lime juice to increase risk of HIV infection and thus
plans for the expanded study was aborted.

4. Phase III SAVVY trial: Nigeria was also engaged in the phase III
SAVVY trial – the testing of a potential microbicide to see if it
was effective. The study was conducted in University College
Hospital, Ibadan and the National Institute of Medical Research,
Lagos between 2004 and 2007. 2140 HIV negative women were enrolled into the study. The research was not able to demonstrate that the product was effective in preventing HIV infection

5. Phase III CS3 trial: Phase III CS3 trials were also conducted in
the Lagos University Teaching Hospital, Lagos and the University of
Port Harcourt between 2004 and 2007. 2160 women were to be enorolled into the study. The study was terminated when the conterpart study conducted in South Africa showed that the product had a potential to increase HIV infection in those that used them

6. Phase IIb oral prophylactic use of tenofovir: Nigeria was also
engaged with the study of the possible use of an antiretroviral
(tenofovir) as a possible drug to prevent HIV infection. Past
studies have shown that this concept – the use of a treatment drug
to prevent infection – is feasible as demonstrated with malaria,
tuberculosis and even with the prevention of mother to child
transmission of HIV. The study in Nigeria was however, halted very
early as the study site could not maintain good clinical practice
standards that was satisfactory.

7. TMC 120 microbicide study: A study was conducted in Nassarawa to measure cross- sectional seroincidence (this means doing a research on a number of HIV-infected people you gather together through some recruitment strategies at a single point in time to estimate how many of these people are newly HIV infected every year). This study conducted with IPM has come to an end. The data has been analysed by the investigator and there may be some interesting information to share with the Nigerian populace that we can learn from. Such information may be pointers to the rate of new HIV infection in some populations in Nassarawa State. IPM would however not go into the next phase of research with the site in Nassarawa State. For IPM, the next stage would be to do a prospective sero-incidence study (this is a study in which people who are not infected are followed up for about a year and you determine how many get HIV infection within that period). IPM has decided to concentrate its work in Southern and Eastern African countries for now. Although IPM is not supporting further incidence studies, there is such a study going on currently in Nigeria through HVTN support for future HIV vaccine studies in Nigeria. IPM may consider doing other forms of study in the country, including possible acceptability studies. Currently, potential difficulties in delivering study products in Nigeria through the custom agency is a considerable barrier that the country needs to address to facilitate study efforts.

8. HIV Vaccine studies: There are also indications that there may be
some new HIV Vaccine related studies that would be conducted in the
near future in Nigeria. The Military Hospital is gearing up for
this. There was a sero-incidence study conducted in Asokoro
Hospital, Abuja for this same reason Nigeria has contributed in so many significant ways to the development of New HIV Prevention Technology. We look forward to the country hosting more studies in the future as this may help answer a few peculiar West African related differences in the global epidemiology of HIV infection.