Effect of Gender and HIV Infection on Zidovudine and Lamivudine Pharmacokinetics

Phase 4

Completed

• Conditions: HIV
• Interventions: Drug: zidovudine 300mg and lamivudine 150mg as Combivir

• Registration Number: NCT01386970
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2008-07
• Study Completion: 2010-07
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-30
• Study First Posted: 2011-07-01
• Results First Submitted: 2020-02-14
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-02
• Last Update Submitted: 2020-03-02
• Results First Posted: 2020-03-16
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Documented physician-diagnosed HIV-infection (HIV+ antibody or plasma HIV-RNA+); HIV-negative volunteers must have a negative HIV-ELISA.
• Age 18 to 55 years;
• Either antiretroviral naïve, or no HIV-therapy in the preceding 6 months;
• Planned antiretroviral regimen includes standard doses of ZDV plus 3TC as part of the antiretroviral regimen. Once- or twice-daily 3TC will be allowed.

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Exclusion Criteria

• Any medical condition that in the opinion of the investigators would jeopardize the intent of the study.
• In the opinion of the investigator, any concomitant immunomodulatory medications, chemotherapeutic agents, investigational drugs, and alternative therapies, including, glucocorticoids, recombinant growth factors or cytokines (e.g. Granulocyte-macrophage colony-stimulating factor, Granulocyte colony-stimulating factor, interferon-alpha or gamma, human growth hormone, etc), ribavirin, birth-control pills, and sex hormones that could interfere with the cellular pharmacology of the study medications;
• Concomitant medications that interfere with renal drug clearances including, tenofovir, adefovir, cidofovir, ganciclovir, probenecid, or any similarly problematic medication in the opinion of the investigators;
• Concomitant warfarin or daily aspirin (to prevent excess bleeding from biopsy).
• Pregnancy or a plan to become pregnant, or menopause;
• Any > or = grade II abnormality in hemoglobin, absolute neutrophil count, routine liver function tests, serum creatinine, or other organ function abnormalities.
• Any medical or personal condition that, in the judgment of the investigators, may influence the subject's ability to comply with study conditions, such as active mental illnesses, or plans to leave the geographical area.
• Inability to give informed consent.
• Triple nucleoside analog reverse transcriptase regimens.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV-negative	zidovudine 300mg and lamivudine 150mg as Combivir	This group was used to compare intracellular ZDV- and 3TC-triphosphate concentrations to the HIV-infected group and in men versus women.
HIV-infected	zidovudine 300mg and lamivudine 150mg as Combivir	This group was started on ZDV-3TC based therapy. Intracellular ZDV- and 3TC-triphosphate concentrations were compared in men versus women and the HIV-negative group.

Primary Outcome Measures

Name	Time	Method
ZDV-TP Drug Levels Compared Between HIV Negative and HIV Infected Subject	Day 12 of dosing	To compare ZDV- triphosphate concentrations in HIV-negative versus HIV-infected subjects.
3TC-TP Drug Levels Compared Between HIV Negative and HIV Infected Subject	Day 12 of dosing	To compare 3TC- triphosphate concentrations in HIV-negative versus HIV-infected subjects.

Trial Locations

Locations (1)

University of Colorado Denver and Health Sciences Center; 🇺🇸 Aurora, Colorado, United States