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- The Investigational New Drug Application (IND) for Phase I of the trial with Harvard Medical School (supported by the NIH) has been approved by the FDA in January 2008. Phase I of the trial is expected to start before the end of the first quarter of 2008.
- Merck's HIV vaccine candidate was in phase I and II studies when discontinuation of the trials was announced on 21 September 2007. The discontinuation of the studies was not related to the use of Crucell's technology.
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Human immunodeficiency virus or HIV is a retrovirus that causes acquired immune deficiency syndrome (AIDS), a condition in humans in which the immune system begins to fail, leading to life-threatening infections. HIV infection is pandemic. As of January 2006, a Joint United Nations Programme on HIV/AIDS (UNAIDS) and the World Health Organization (WHO) estimate that AIDS has killed more than 25 million people since it was first recognized on December 1, 1981 making it one of the most destructive pandemics human history. According to an UNAIDS/WHO 2006 AIDS Epidemic Update release late last year, an estimated 39.5 million people are living with HIV. There were 4.3 million new infections in 2006 with 2.8 million (65%) of these occurring in sub-Saharan Africa and important increases in Eastern Europe and Central Asia, where there are some indications that infection rates have risen by more than 50% since 2004. In 2006 alone, 2.9 million people died of AIDS-related illnesses. In 2005, an estimated 2,5 million people died from AIDS, a third of which emerged from sub-Saharan Africa further denting the region’s hopes of economic progress.
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Sub-Saharan Africa is more seriously affected by HIV and AIDS than any other region of the world. An estimated 24.5 million people were living with HIV at the end of 2005 and approximately 2.7 million additional people were infected with HIV during that year, according to official UNAIDS statistics. More than twelve million children have been orphaned by AIDS. Both HIV prevalence rates and the numbers of people dying from AIDS vary significantly between African countries. In Somalia and Senegal for example, the HIV prevalence is under 1% of the adult population, whereas in South Africa and Zambia, around 15-20% of adults are infected with HIV. Recent figures have shown a dramatic increase of HIV/AIDS cases in South & South East Asia.
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HIV is transmitted through direct contact of a mucous membrane or the bloodstream with a bodily fluid containing HIV, such as blood, semen, vaginal fluid, preseminal fluid, and breast milk. This transmission can come in the form of anal, vaginal or oral sex, blood transfusion, contaminated hypodermic needles, exchange between mother and baby during pregnancy, childbirth, or breastfeeding, or other exposure to one of the above bodily fluids. Mother-to-child transmission (MTCT) of HIV is also possible when a child is infected with HIV during pregnancy or through breastfeeding as a result of having an HIV-infected mother.
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Opportunistic infections such as Pneumocystis carinii are common in people with AIDS. People with AIDS also have an higher risk of developing various cancers such as Kaposi's sarcoma, cervical cancer, and cancers of the immune system known as lymphomas. Weight loss is another typical symptom associated with Aids patients.
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There currently is no treatment for HIV or AIDS. The only known methods of prevention are based on avoiding exposure to the virus or, failing that, an antiretroviral treatment directly after a highly significant exposure, called post-exposure prophylaxis (PEP). Protective sex is another way of prevention from the deadly disease. Antiretroviral drugs (ARVs) - which significantly delay the progression of HIV to AIDS and allow people living with HIV to live relatively normal, healthy lives – have been available in richer parts of the world since around 1996.
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In August 2005, Crucell along with Harvard Medical School, was awarded a US$ 19.2 million (€Euro 15.9 million) grant by US National Institutes of Health (NIH) to develop new adenovirus vector-based vaccines against HIV/AIDS. Having entered into an agreement in early 2004, Crucell and the International AIDS Vaccine Initiative (IAVI) jointly announced November 2004 that they had signed an agreement whereby Crucell would develop AdVac® vectors for use in IAVI's AIDS vaccine development program. The Investigational New Drug Application (IND) for Phase I of the trial with Harvard Medical School (supported by the NIH) has been approved by the FDA in January 2008. Phase I of the trial is expected to start before the end of the first quarter of 2008.
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