Status:
TERMINATED
Kaletra and Viread in Antiretroviral Naïve Patients
Lead Sponsor:
Oklahoma State University Center for Health Sciences
Collaborating Sponsors:
Abbott
Conditions:
HIV Infections
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Once daily antiretroviral therapy with Viread (tenofovir DF, 300mg) plus Kaletra (LPV/r, 800mg/200mg) will be effective in suppressing and maintaining suppression of HIV RNA to \<50 copies/ml in antir...
Detailed Description
This study is a phase IV prospective, open-label, controlled treatment protocol consisting of once daily Kaletra dosed at 800mg lopinavir with 200mg ritonavir in four combination tablets plus Viread d...
Eligibility Criteria
Inclusion
- Male or female patients \>18 years of age with documented HIV-1 infection
- Naïve to antiretroviral therapy
- Able and willing to provide written informed consent
- No CD4 restriction
- HIV-1 RNA levels \>5000 c/mL
- Female patients must meet these additional criteria
- Non-childbearing potential
- Negative serum pregnancy test at screen
- Willingness to abstain from sexual intercourse or use double barrier contraception
Exclusion
- Presence of any of the following:
- Aminotransferases \>3xULN
- Hemoglobin concentration \<8.0g/dl
- Absolute neutrophil count \<800 cells/cubic mm
- Platelet count \<50,000 cells/cubic mm
- Acute illness, or an acute illness ≤7 days
- Presence of Opportunistic Infection, or an OI within 30 days of screening
- Acute or chronic active Hepatitis B
- Hepatitis C
- Creatinine Clearance \<50 mL/min
- Pregnant or breast-feeding women
- Presence of any illness, physical or behavioral conditions (i.e., substance abuse, excluding cannabis) that will impair the patient's ability participate
- Patient who, in the opinion of the investigator, will be unlikely to complete the study protocol and adhere to the study drug regimens
- Concurrent use of medications that may potentially interact with study medications including: astemizole, terfenadine, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's wort, lovastatin, simvastatin, pimozide, midazolam, triazolam, adefovir, cidofovir, acyclovir, ganciclovir, and valganciclovir.
- Patient suffers from a serious medical condition that may in the opinion of the investigator compromise his or her safety.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00679926
Start Date
May 1 2008
End Date
May 1 2011
Last Update
December 4 2020
Active Locations (1)
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1
OSU Internal Medicine Specialty Clinic
Tulsa, Oklahoma, United States, 74127