NCT00002028 - 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)

Connolly KJ, Allan JD, Fitch H, Jackson-Pope L, McLaren C, Groopman J
A phase I study of 2'-3'-dideoxyinosine (ddI) administered orally twice daily to patients with AIDS or ARC and hematologic intolerance to azidothymidine (AZT). Int Conf AIDS. 1990 Jun 20-23;6(3):204 (abstract no SB473)

A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-Dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir)

Details for clinical trial NCT00002028

Clinical trial NCT00002028 - References