FDA Issues Draft Guidance on Developing HIV Prevention Drugs
Clinical trials for HIV prevention drugs should generally involve two well-controlled trials, but a single Phase III trial can suffice if the results are supported by additional evidence, the FDA said in a new draft guidance.
The trial populations should include healthy, sexually active adults who have not contracted HIV but are at substantial risk, the agency said. For trial subjects who are men who have sex with men, the trials can either be superiority trials or non-inferiority trials.
In trials for high-risk women, the FDA recommends only superiority designs because the historical evidence of prevention efficacy in at-risk women makes determining a non-inferiority margin difficult to impossible.