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Effect of Gender and HIV Infection on Zidovudine and Lamivudine Pharmacokinetics

NCT01386970 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2020-03-16

Study results available
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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.

Conditions

Interventions

DRUG

zidovudine 300mg and lamivudine 150mg as Combivir

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Hawaii

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Peter L. Anderson, PharmD · University of Colorado Denver and Health Sciences Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2008-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01386970 on ClinicalTrials.gov