Clinical trial NCT00679926: Kaletra and Viread in Antiretroviral Naïve Patients
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV
AIDS
HIV/AIDS
Treatment Naive
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2008-05-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 antiretroviral naïve patients through 48 weeks of therapy.

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 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.

Primary outcomes:
measure: 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.
timeFrame: 4, 8, 12, 16, 24, 32, 40, and 48 weeks
Secondary outcomes:
measure: Proportion of Patients With <400copies/ml
timeFrame: 4,8, and 12 weeks
measure: Review Virologic Response to Assess Rate of Viral Decline.
timeFrame: weeks 4, 8, 12, 16, and 24
measure: Proportion of Patients With <50 Copies/ml HIV-1 RNA
timeFrame: at weeks 4, 8, 12, 16, 24, 32, 40, and 48
measure: Change From Baseline CD4 Counts
timeFrame: at weeks 4, 8, 12, 16, 24, 32, 40, and 48
measure: Time to Virologic Failure.
timeFrame: Week 48
measure: Tolerability and Adverse Events.
timeFrame: 48 weeks
measure: Change From Baseline Fasting Total Cholesterol and Fasting Triglyceride Levels.
timeFrame: 48 weeks
measure: Characterize Adherence Rates for This Therapeutic Regimen by the Use of Medication Electronic Monitoring Systems (MEMS) Caps.
timeFrame: 48 weeks
measure: Characterize Adherence Rates for This Therapeutic Regimen by Use of Pharmacy Refill Records.
timeFrame: 48 weeks
measure: Assess Genotypic Changes in Patients With Virologic Failure.
timeFrame: 48 weeks
measure: Assess Lopinavir Trough Levels in Patients Failing to Obtain Virologic Suppression.
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: OSU Internal Medicine Specialty Clinic
state: Oklahoma
Study officials:
affiliation: Oklahoma State University Center for Health Sciences
name: Damon Baker, D.O.
role: PRINCIPAL_INVESTIGATOR
References: