The company agrees that if the vaccine proves effective it will be given free of charge to the addict population of the city and at cost to the country for five years. This will be a randomized double blind prospective study with one group receiving the test vaccine and the other group receiving a placebo. This means that all infections are treated but no patient is given either retroviral drugs, including AZT, or any protease inhibitors. If there is any change in the standard therapy recommended by the government, any previous or future seroconvertor will be switched to this therapy. The Municipal Corporation will provide treatment for the patient's lifetime.
Individuals can drop out at any time without fear of prejudice.
Informed consent will be obtained by first briefing possible participants about the study, including the experimental nature of the vaccine, and the treatment policy. Two days following the initial briefing the individuals return to the Institute where they are given a brief oral and written exam to see if they fully understand the study and their rights. Only if they pass the test, are they enrolled. The study is submitted to the Ethical Review Board of the Institute and to a firm that conducts ethical reviews for companies in the private sector who wish to conduct research on human subjects. That Subcommittee approves the protocol and forwards it to the Ministry of Public Health Ethical Committee.