NCT00398996 - 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)

Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray A, Gengiah T, Nair G, Bamber S, Singh A, Khan M, Pienaar J, El-Sadr W, Friedland G, Abdool Karim Q
Timing of initiation of antiretroviral drugs during tuberculosis therapy. N Engl J Med.
Abdool-Karim SS, Abdool-Karim Q, Friedland G, Lalloo U, El-Sadr WM; START project
Implementing antiretroviral therapy in resource-constrained settings: opportunities and challenges in integrating HIV and tuberculosis care. AIDS. 2004 Apr 30;18(7):975-9. Review.

Study to Compare Three Existing Starting Points of ART Initiation in HIV/TB Co-infected Patients

Clinical trial NCT00398996 - References