NCT00455585 - 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)

Hosseinipour M C, C
A., Kanyama C, Mshali I. Pharmacokinetic Comparison of Generic and Trade Formulations of Lamivudine, Stavudine and Nevirapine in HIV-infected Malawian Subjects. in 12th Conference on Retroviruses and Opportunistic Infections. 2005. Boston. 17.
JA Gogtay, V
M., VG Nayak, PV Bodhe, A Dasgupta, V Srivatsan, G Vaidyanathan, KC Patel. A pharmacokinetic evaluation of lamivudine, stavudine and nevirapine given as a fixed dose combination pill versus the same three drugs given safely in healthy human volunteers. in 6th International Congress on Drug Therapy in HIV Infection. 2002. Glasgow,UK. 16.
Laurent C, Kouanfack C, Koulla-Shiro S, Nkoué N, Bourgeois A, Calmy A, Lactuock B, Nzeusseu V, Mougnutou R, Peytavin G, Liégeois F, Nerrienet E, Tardy M, Peeters M, Andrieux-Meyer I, Zekeng L, Kazatchkine M, Mpoudi-Ngolé E, Delaporte E
Effectiveness and safety of a generic fixed-dose combination of nevirapine, stavudine, and lamivudine in HIV-1-infected adults in Cameroon: open-label multicentre trial. Lancet. 2004 Jul 3-9;364(9428):29-34.

Comparison of the Steady State Pharmacokinetics of Nevirapine, Stavudine Plus Lamivudine in HIV Positive Ugandan Patients Taking Triomune 40 With the Pharmacokinetics of the Originator Products.

Details for clinical trial NCT00455585

Clinical trial NCT00455585 - References