IAVI Report - March / April 2002

Firsts for the Global Fund
The Board of Directors of the Global Fund to Fight AIDS, Tuberculosis and Malaria met in New York City for three marathon days (22-24 April) to make its first funding decisions and further define its mission. The Board approved US$ 378 million over two years to 40 programs in 31 countries. A second round of 18 proposals from 12 countries may receive $238 million, contingent on substantial changes and clarifications. The first round of funding disbursements drew mixed responses, as praise for the new infusion of money mingled with concern that few of the proposals included interventions like antiretroviral treatment and first-line treatments for drug-resistant tuberculosis and malaria that are recognized as essential components of an effective, integrated response to these epidemics. Virtually all involved agreed that more money is needed. The Fund currently has pledges for $2 billion to fight all three diseases—a small portion of the $7-10 billion in global spending called for by UN Secretary General Kofi Annan just to fight HIV/AIDS.

The Board also selected its first permanent executive director, Dr. Richard Feachem, founding director of the Institute for Global Health (Berkeley, California) and former Director and Senior Advisor for Health Nutrition and Population at the World Bank from 1995 to 1999. Feachem is expected to take the helm in July 2002, with interim executive director Anders Nordström serving until then. Also in July, the Fund plans to release revised guidelines for the second round of funding, which will be decided upon in late 2002.

Novel "Pre-Screening" Study Starts in Soweto
How do you find low-risk volunteers for HIV vaccine trials in a community where up to 30% of its members are already infected? This March, the Vaccine Trials Unit (VTU) at Chris Hani Baragwanath Hospital in Soweto, South Africa, launched an innovative "prescreening" protocol addressing this conundrum.

Designed by VTU head Efthyia Vardas and colleagues, the protocol offers adults voluntary counseling and testing at centers in Johannesburg and Soweto. After an initial negative test, interested volunteers are invited to enroll in the full protocol, which involves monthly testing (with pre- and post-test counseling) for HIV and STIs and bi-weekly "vaccine discussion groups" that cover vaccine trials from soup to nuts. (Vardas says that the protocol originally called for one meeting per month, but the community wanted more.)

After six months, HIV-negative participants will be offered enrollment in the site's planned vaccine trials (several potential candidates are being considered for Phase I studies). Those in the protocol who test positive can attend an HIV-positive support group and receive referrals to local care centers.

The protocol aims to enroll 40 individuals a month. Already on board: teachers, social workers and a Catholic priest.

India Announces First-Ever National AIDS Policy
On 4 April 2002, India—a country where nearly 4 million people are living with HIV/AIDS—released its first national AIDS policy. The document reflects a fundamental shift in the government's view of the AIDS epidemic, away from a crisis affecting only public health to "a developmental issue with deep socio-economic implications."

The comprehensive National AIDS Prevention and Control Policy (NAPCP) (naco.nic.in/vsnaco/nacp/ctrlpol.htm) builds on lessons learned from a recently-concluded "phase I" program of the National AIDS Control Organisation (NACO). It stresses that, while the federal government must take the lead in forging a response to the epidemic, program implementation must be decentralized to the State and local levels.

The policy provides a framework for improving support of infected people and expanding prevention efforts to include more comprehensive surveillance and universal access to treatments that reduce mother-to-child transmission. But its overriding message is the need for a multisectoral, "holistic" approach to the crisis, demanding deepened commitment across government branches, NGO's and international groups.

Candid in its recognition of the devastating effects of social stigmatization and discrimination against PLWHA's, the NAPCP also seeks to provide stronger legislative, legal and social protections for human rights. It also calls for access to palliative care and drugs to treat opportunistic infections, but does not include plans for expanding access to anti-retroviral drugs.

Annexed to the NAPCP was a new National Blood Policy mandating tighter regulation of blood banks and screening. HIV-contaminated blood accounts for nearly 4% of all new infections in India.

Thailand Reconstitutes AIDS Vaccine Subcommittee
On 13 March 2002, Thailand officially appointed a new Subcommittee for HIV/AIDS Vaccine Development and Trials, replacing the group which dissolved nearly a year ago in the wake of controversy over a proposed therapeutic vaccination study (see IAVI Report, Vaccine Briefs, Dec 2000/Jan 2001, "Controversies Keep Thai Remune® Trial Hanging"). The move comes not a moment too soon, with the country planning to launch its second Phase III trial later this year in southern Thailand (as a collaboration of the US Army vaccine program, Thailand's Royal Army and Ministry of Health).

The Subcommittee is chaired by Prasert Thongcharoen of Mahidol University, a leading virologist and central figure in Thailand's early, aggressive response to AIDS, which included a strong commitment to vaccine development. The group's six additional members bring expertise in areas ranging from immunology, infectious disease and epidemiology to family planning, women's development and human rights.

The subcommittee's immediate task is to review the protocol for the upcoming Phase III trial, which will test a prime-boost combination of a canarypox-based HIV vaccine (ALVAC vCP152) and gp120, in a community-based cohort of nearly 15,000 volunteers. The WHO/UNAIDS Group on HIV Vaccines will also provide an informal review, and submissions to the relevant Institutional Review Boards in Thailand and the US have begun.

As for the difficulties that led to the committee's dissolution, it now appears that the controversial vaccine Remune^® will henceforth be treated in Thailand as a drug, not a vaccine—sending it down a separate regulatory path.

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©2002. The IAVI Report.

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