drugset / Trial / NCT00002379

The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined With Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs

NCT00002379

Phase 2 Completed 100 enrolled Gilead Sciences
Treatment

Summary

To evaluate the safety and tolerance of adefovir dipivoxil and indinavir administered orally in combination with zidovudine, lamivudine, or stavudine in HIV-infected patients with CD4 cell counts \>= 100 cells/mm3 and an HIV-1 RNA baseline copy number \>= 5000 copies/ml. To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (500 copies/ml) by 20 weeks of study therapy and the average reduction in HIV-1 RNA from baseline through study week 20. To evaluate the durability of the antiviral response through 48 weeks of study in patients who continue on study therapy after week 24.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Adefovir dipivoxil Small molecule Oral
Subject INDINAVIR ANHYDROUS Other / unclassified Oral
Subject Lamivudine Other / unclassified
Subject Stavudine Other / unclassified
Subject Zidovudine Small molecule
Background L-carnitine Other / unclassified