Kaletra and Viread in Antiretroviral Naïve Patients
Information source: Oklahoma State University Center for Health Sciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Lopinavir/ritonavir and tenofovir (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Oklahoma State University Center for Health Sciences Official(s) and/or principal investigator(s): Damon Baker, D.O., Principal Investigator, Affiliation: Oklahoma State University Center for Health Sciences
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 antiretroviral naïve patients through 48 weeks of therapy.
Clinical Details
Official title: A Phase IV Open Label Investigation of the Efficacy and Durability of Once Daily Antiretroviral Therapy With Kaletra and Viread in Antiretroviral Naïve Patients.
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To assess the efficacy of once daily antiretroviral therapy with Viread 300mg and Kaletra 800mg/200mg in suppressing HIV RNA levels to <50 copies/ml in antiretroviral naïve patients.
Secondary outcome: Proportion of patients with <400copies/mlReview virologic response to assess rate of viral decline. Proportion of patients with <50 copies/ml HIV-1 RNA Change from baseline CD4 counts Time to virologic failure. Tolerability and adverse events. Change from baseline fasting total cholesterol and fasting triglyceride levels. Characterize adherence rates for this therapeutic regimen by the use of Medication Electronic Monitoring Systems (MEMS) caps. Characterize adherence rates for this therapeutic regimen by use of pharmacy refill records. Assess genotypic changes in patients with virologic failure. Assess lopinavir trough levels in patients failing to obtain virologic suppression.
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 dosed as 300 mg tenofovir DF. This will be a single site,
multi-investigator, study for 48 weeks. Consecutive eligible patients will be enrolled into
the study to reach the enrollment goal of 30 patients. Eligible patients will be identified
and screened during routine initial or follow-up visits at the Internal Medicine Specialty
Services Clinic. This clinic serves as the HIV/AIDS specialty care clinic and is a
subdivision of the Department of Internal Medicine, Oklahoma State University Center for
Health Sciences College of Osteopathic Medicine. The study site currently serves >700
persons living with HIV in northeast Oklahoma with four to five antiretroviral naïve
patients seen each week.
Patients meeting all inclusion criteria will receive routine standard of care for our
program as prescribed by the DHHS guidelines. Patients will have a Complete Blood Count
(CBC), Complete Metabolic Profile (CMP), fasting lipid profile, CD4 count, HIV-1 RNA level,
and other prescribed or indicated laboratory preformed at baseline and throughout the study
as described in the Visits and Evaluations section of this protocol. All of the
aforementioned laboratory tests will be performed at the Diagnostic Laboratories of
Oklahoma, a division of Quest Diagnostics. Any antiretroviral resistance testing will be
performed at Virologic Labs, Inc. Adherence will be assessed at discontinuation of the
study and when indicated for evaluation of virologic failure by Memory Electronic Monitoring
Systems caps and pharmacy refill data. Patients will be monitored at each study visit for
tolerability and adverse events. Patients who develop a study related Grade 1 or 2 Adverse
Events (Aes) may continue the study. Those who develop Grade 3 or 4 AEs will have study
medications discontinued. Patients with asymptomatic elevations of triglyceride or Low
Density Lipoprotein (LDL) cholesterol levels may be treated with appropriate lipid lowering
therapy at the investigators discretion.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or female patients >18 years of age with documented HIV-1 infection
2. Naïve to antiretroviral therapy
3. Able and willing to provide written informed consent
4. No CD4 restriction
5. HIV-1 RNA levels >5000 c/mL
6. Female patients must meet these additional criteria
1. Non-childbearing potential
2. Negative serum pregnancy test at screen
3. Willingness to abstain from sexual intercourse or use double barrier
contraception
Exclusion Criteria:
1. Presence of any of the following:
1. Aminotransferases >3xULN
2. Hemoglobin concentration <8. 0g/dl
3. Absolute neutrophil count <800 cells/cubic mm
4. Platelet count <50,000 cells/cubic mm
5. Acute illness, or an acute illness ≤7 days
6. Presence of Opportunistic Infection, or an OI within 30 days of screening
7. Acute or chronic active Hepatitis B
8. Hepatitis C
9. Creatinine Clearance <50 mL/min
2. Pregnant or breast-feeding women
3. Presence of any illness, physical or behavioral conditions (i. e., substance abuse,
excluding cannabis) that will impair the patient's ability participate
4. Patient who, in the opinion of the investigator, will be unlikely to complete the
study protocol and adhere to the study drug regimens
5. 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.
6. Patient suffers from a serious medical condition that may in the opinion of the
investigator compromise his or her safety.
Locations and Contacts
OSU Internal Medicine Specialty Clinic, Tulsa, Oklahoma 74127, United States
Additional Information
Starting date: May 2008
Last updated: October 9, 2012
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