How and why will bone density be studied in VOICE?
In previous animal studies of tenofovir, very high doses of the drug (many times higher than the dose given to humans) were found to have an adverse effect on the animals’ bone health. In addition, an ongoing clinical study of HIV-infected men and women taking tenofovir as part of an antiretroviral drug treatment regimen has found measurable decreases in the density of spine and hip bones, although these decreases have not adversely affected the individuals’ health. Thus, the VOICE study investigators want to learn what effects, if any, tenofovir has on the bone density of healthy, HIV-uninfected women. The study team will monitor the bone density of all clinical trial participants. In addition, about 300 study participants taking the oral tenofovir or tenofovir/emtricitabine (Truvada) tablets at sites in Uganda and Zimbabwe will enroll in a sub-study called VOICE B. The VOICE B participants will periodically undergo specialized testing of bone-mineral density so investigators can moni
