Kaletra and Viread in Antiretroviral Naïve Patients

Stopped early · Phase 4

Conditions studied: HIV Infections

In brief

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 antiretroviral naïve patients through 48 weeks of therapy.

Key facts

Study ID

NCT00679926

Run by

Oklahoma State University Center for Health Sciences

People needed

6

Starts

2008-05-01

Expected to finish

2011-05-01

Last updated by the study team

2020-12-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• OSU Internal Medicine Specialty Clinic — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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