NCT00000719 - 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)

Bozzette S, Skowron G, Arrezo J, Spector SA, Pettinelli C, Richman DD
ACTG 050: alternating (alt) and intermittent (INT) ddc and AZT in the treatment of persons with advanced HIV infection and hematologic intolerance to AZT. Int Conf AIDS. 1990 Jun 20-23;6(3):192 (abstract no SB425)
Bozzette SA, Richman DD
Salvage therapy for zidovudine-intolerant HIV-infected patients with alternating and intermittent regimens of zidovudine and dideoxycytidine. Am J Med. 1990 May 21;88(5B):24S-26S. Review.
Fichtenbaum CJ, Clifford DB, Powderly WG
Risk factors for dideoxynucleoside-induced toxic neuropathy in patients with the human immunodeficiency virus infection. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Oct 1;10(2):169-74.
Gries JM, Troconiz IF, Verotta D, Jacobson M, Sheiner LB
A pooled analysis of CD4 response to zidovudine and zalcitabine treatment in patients with AIDS and AIDS-related complex. Clin Pharmacol Ther. 1997 Jan;61(1):70-82.
Lathey JL, Marschner IC, Kabat B, Spector SA
Deterioration of detectable human immunodeficiency virus serum p24 antigen in samples stored for batch testing. J Clin Microbiol. 1997 Mar;35(3):631-5.
LeLacheur SF, Simon GL
Exacerbation of dideoxycytidine-induced neuropathy with dideoxyinosine. J Acquir Immune Defic Syndr (1988). 1991;4(5):538-9.

A Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease

Clinical trial NCT00000719 - References