Kaletra and Viread in Antiretroviral Naïve Patients

NCT ID: NCT00679926

Last Updated: 2020-12-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2011-05-31

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.

Conditions

HIV Infections

Keywords

HIV; AIDS; HIV/AIDS; Treatment Naive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Once daily

Patients taking 4 (four) lopinavir/ritonavir (200mg/50mg tablets) and 1 (one) tenofovir (300mg tablet) every 24 (twenty four) hours.

Group Type: EXPERIMENTAL

Once daily

Intervention Type: DRUG

Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily

Interventions

Once daily

Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily

Intervention Type: DRUG

Other Intervention Names

Kaletra; Viread

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Oklahoma State University Center for Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Johnny Stephens

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Damon Baker, D.O.

Role: PRINCIPAL_INVESTIGATOR

Oklahoma State University Center for Health Sciences

Locations

OSU Internal Medicine Specialty Clinic

Tulsa, Oklahoma, United States

Countries

United States

Other Identifiers

Baker - 001

Identifier Type: -

Identifier Source: org_study_id