NCT00001267

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (planned)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• AIDS-Related Complex
• Acquired Immunodeficiency Syndrome

Interventions

Type	Name	Description
DRUG	zidovudine
DRUG	2',3'-dideoxyinosine

Timeline

• Start date: 1990-10-01
• Completion: 2000-04-01
• First posted: 2002-12-10
• Last updated: 2008-03-04

Locations

1 site across 1 country: United States