Monitoring for Side Effectsa

Monitoring for Side Effects

The health of participants is closely monitored throughout each trial, and participants are linked to any necessary medical care. In addition to scheduled reviews of safety data by the DSMB, both clinical and behavioral safety are closely monitored on an ongoing basis.

Although the drugs being tested have excellent safety profiles, there are potential medical risks. Tenofovir use in HIV-infected people has been associated with a relatively low level of side effects such as rash, diarrhea, headache, pain, depression, fatigue, and nausea, as well as rare but more serious effects, such as impaired kidney function, reductions in bone density, redistribution/accumulation of body fat, and lactic acidosis (a build-up of lactic acid in the blood).

Tenofovir plus emtricitabine has similarly been associated with a relatively low level of side effects in HIV-infected people, including diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash, with infrequent reports of impaired kidney function, reductions in bone density, redistribution/accumulation of body fat, and lactic acidosis. For both drugs, side effects usually resolve after use of the drug is discontinued.

Careful monitoring of participants is provided using laboratory testing for any biological abnormalities (such as elevated creatinine or decreased phosphorus), so that the drug being tested can be promptly discontinued if serious concerns are identified. CDC works with partners in each community to ensure that care is provided if either drug results in any health problems during the trial.