Background: The incidence of HIV and AIDS is growing faster among individuals 50 and older compared to those under 40. Although the majority of clinical trials aimed at treating diseases have been found to exclude older individuals, it is not yet known whether this bias extends to sexually transmitted disease (STD) risk-reduction clinical trials published in a wide range of journals.
Methods: We conducted a systematic review of STD risk-reduction clinical trials that were published in the English-language journals included in MEDLINE between January 1, 1994, and January 1, 2005.
Results: Over two-thirds (73%) of these clinical trials excluded persons over the age of 50 and 89% excluded persons over the age of 65. The level of inclusion of these older individuals showed no improvement during the 10 years of the systematic review.
Conclusions: The pattern of excluding individuals above the age of 50 from STD risk-reduction clinical trials has persisted even though AIDS is increasing most rapidly in this age group. Therefore, a need exists to increase older individuals' representation in these clinical trials.