CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed
Drug / intervention
zidovudine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00432016
NCT00432016Phase 2Completed

A Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerance, Pharmacokinetics and Antiviral Activity of Amdoxovir and Zidovudine in Untreated HIV-1 Infected Subjects Currently Untreated

RFS Pharma, LLC·interventional·Posted Feb 6, 2007·Updated May 11, 2007

In Brief

A Phase 2 clinical trial evaluating zidovudine, amdoxovir, and 1 other intervention for HIV Infections. Completed, across 1 site.

Detailed Summary

The purpose of this study is to determine the short term safety, tolerance, and antiviral effect of zidovudine (AZT) and amdoxovir (AMDX, DAPD) in combination, and whether the dosage for AZT can be reduced, potentially decreasing side effects, while maintaining antiviral effects. Study hypothesis: DADP in combination with AZT is safe and effective, and AZT dosing may be reduced, resulting in lower levels of AZT-monophosphate associated with toxicity and maintaining levels of AZT-triphosphate associated with efficacy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesArgentina
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2007
Enrollment StartFeb 1, 2007
Study CompletionMay 1, 2007
TodayJul 2, 2026
Posted 19.4 years ago

Interventions

zidovudinedrug

amdoxovirdrug

pharmacokinetic samplingprocedure