Effect of Gender and HIV Infection on Zidovudine and Lamivudine Pharmacokinetics

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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HIV-negative

This group was used to compare intracellular ZDV- and 3TC-triphosphate concentrations to the HIV-infected group and in men versus women.

Group Type ACTIVE_COMPARATOR

zidovudine 300mg and lamivudine 150mg as Combivir

Intervention Type DRUG

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

HIV-infected

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.

Group Type ACTIVE_COMPARATOR

zidovudine 300mg and lamivudine 150mg as Combivir

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes