Clinical Trial: A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex With an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex With an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine

Brief Summary: Several dideoxynucleosides have now been shown to have activity against HIV but to have different toxicities. This study will involve therapy of patients with AIDS or ARC with two of these agents, AZT and 2', 3'-dideoxyinosine (ddI), which have different toxicity profiles, over a 2-year period of time. The rationale for using the two drugs will be to reduce toxicity and also possibly to delay or prevent the development of resistance. Patients will be randomized to receive either an alternating regimen or a continuous simultaneous regimen with these two drugs. The study will be structured as a randomized pilot study.

Detailed Summary: Several dideoxynucleosides have now been shown to have activity against HIV but to have different toxicities. This study will involve therapy of patients with AIDS or ARC with two of these agents, AZT and 2', 3'-dideoxyinosine (ddI), which have different toxicity profiles, over a 2-year period of time. The rationale for using the two drugs will be to reduce toxicity and also possibly to delay or prevent the development of resistance. Patients will be randomized to receive either an alternating regimen or a continuous simultaneous regimen with these two drugs. The study will be structured as a randomized pilot study.
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Institutes of Health Clinical Center (CC)

Dates:
Date Received: November 3, 1999
Date Started: October 1990
Date Completion: April 2000
Last Updated: March 3, 2008
Last Verified: August 1999