NCT00194545 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Farquhar C, Wamalwa D, Selig S, John-Stewart G, Mabuka J, Majiwa M, Sutton W, Haigwood N, Wariua G, Lohman-Payne B
Immune responses to measles and tetanus vaccines among Kenyan human immunodeficiency virus type 1 (HIV-1)-infected children pre- and post-h
Wamalwa DC, Farquhar C, Obimbo EM, Selig S, Mbori-Ngacha DA, Richardson BA, Overbaugh J, Egondi T, Inwani I, John-Stewart G
Medication diaries do not improve outcomes with highly active antiretroviral therapy in Kenyan children: a randomized clinical tri
Wamalwa DC, Farquhar C, Obimbo EM, Selig S, Mbori-Ngacha DA, Richardson BA, Overbaugh J, Emery S, Wariua G, Gichuhi C, Bosire R, John-Stewart G
Early response to highly active antiretroviral therapy in HIV-1-infected Kenyan children. J Acquir Immune Defi
Wamalwa DC, Obimbo EM, Farquhar C, Richardson BA, Mbori-Ngacha DA, Inwani I, Benki-Nugent S, John-Stewart G
Predictors of mortality in HIV-1 infected children on antiretroviral therapy in Kenya: a prospective cohort. BMC Pediatr. 2010 May 18;10:33. doi:

Effect of Medication Diaries on Adherence to Highly Active Antiretroviral Drugs Among HIV-1 Infected Kenyan Children

Clinical trial NCT00194545 - References