NCT00334256 - 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)

Hirt D, Urien S, Ekouévi DK, Rey E, Arrivé E, Blanche S, Amani-Bosse C, Nerrienet E, Gray G, Kone M, Leang SK, McIntyre J, Dabis F, Tréluyer JM; ANRS 12109
Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS
Hirt D, Urien S, Rey E, Arrivé E, Ekouévi DK, Coffié P, Leang SK, Lalsab S, Avit D, Nerrienet E, McIntyre J, Blanche S, Dabis F, Tréluyer JM
Population pharmacokinetics of emtricitabine in human immunodeficiency virus type 1-infected pregnant women and t
TEmAA ANRS 12109 Study group, Arrivé E, Chaix ML, Nerrienet E, Blanche S, Rouzioux C, Coffie PA, Kruy Leang S, McIntyre J, Avit D, Srey VH, Gray G, N'Dri-Yoman T, Diallo A, Ekouévi DK, Dabis F
Tolerance and viral resistance after single-dose nevirapine w

Phase II Trial, Multicentre, Opened Label Evaluating the Pharmacokinetics and the Safety and Toxicity of the Tenofovir-Emtricitabine Combination in Pregnant Women and Infants in Africa and Asia

Details for clinical trial NCT00334256

Clinical trial NCT00334256 - References