CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 43 enrolled
Drug / intervention
zidovudine 300mg and lamivudine 150mg as Combivirdrug
Likely dose
zidovudine 300mg and lamivudine 150mg as Combivirfrom 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/NCT01386970
NCT01386970Phase 4Completed
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Sex and Disease Dependent Nucleoside Analog Toxicity

University of Colorado, Denver·interventional·Posted Jul 1, 2011·Updated Mar 16, 2020

In Brief

A Phase 4 clinical trial evaluating zidovudine 300mg and lamivudine 150mg as Combivir for HIV. Completed, enrolled 43 participants across 1 site.

Detailed Summary

This study evaluated the blood and blood cell concentrations of zidovudine and lamivudine in men versus women and in those with versus without HIV infection. Additionally, markers of side effects were correlated with blood levels of the drugs. The hypothesis was that women and those with HIV would have higher drug levels, as well as markers of side effects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID), University of Hawaii

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 1, 2011
Enrollment StartMay 1, 2005
Primary CompletionJul 1, 2008
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 15.0 years ago

Interventions

zidovudine 300mg and lamivudine 150mg as Combivirdrug

twice daily for 12 days in the HIV-negative group and indefinitely for their care in the HIV-positive group