13. Treatment and Care

Consensus:

For those who contract HIV infection during the course of the trial, but not as a result of the trial, treatment should be provided at a level consistent with that available in the host country. There is no imperative to provide a level of care consistent with that in the sponsoring country, or with the highest available in the world.

Discussion:

It may also be inadequate to provide exactly the same care as that in the host country. As an example, it was considered inappropriate not to use sterile needles for administering the trial vaccines, although sterile equipment may not be generally available in the host country.

It was agreed also that there is some obligation for the sponsor to provide treatment in proportion to its resources. Where treatment is provided to participants, it should be provided to all participants. In the case of discordant couples, it should be provided to the HIV-positive partner. There was significant concern about the risk of disproportionate treatment resulting in undue incentive/inducement for people to participate.

There was concern that a sponsor providing excessively high levels of treatment could exonerate a government from its responsibility to provide treatment for its population.

It was acknowledged that providing treatment at a level consistent with standard practice in the host would make the conduct of trials in developing countries financially attractive to potential sponsors. However, this was viewed by some participants as an acceptable way to attract research activity to a developing country.