NCT00000673 - 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)

Polsky B, Wolitz R, Cantrill H, Chuang EL, Heinemann MH, Sands M, Feinberg JE, Power M, Davis R
Intravitreal (IVL) Ganciclovir (GCV) salvage therapy (Rx) for cytomegalovirus (CMV) retinitis (ACTG 085): a preliminary report. Int Conf AIDS. 1991 Jun 16-21;7(2):267 (abstract no WB2340)
Polsky, et al
Intravitreal ganciclovir salvage therapy for cytomegalovirus retinitis in AIDS: AIDS Clinical Trials Groups Protocol 085. Int J Infect Dis. 1996 Oct; 1(2):70-4

A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy

Details for clinical trial NCT00000673

Clinical trial NCT00000673 - References