Kaletra and Viread in Antiretroviral Naïve Patients

NCT00679926 | Terminated Phase 4 Results

• 1 other identifier: Baker - 001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV; AIDS; HIV/AIDS; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• 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.

  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. This will be done by the proportion of patients with plasma HIV-1 RNA levels M 50 copies/ml at the end of 48 weeks of therapy.

  4, 8, 12, 16, 24, 32, 40, and 48 weeks

Secondary Outcomes (11)

• Proportion of Patients With <400copies/ml

  4,8, and 12 weeks

• Review Virologic Response to Assess Rate of Viral Decline.

  weeks 4, 8, 12, 16, and 24

• Proportion of Patients With <50 Copies/ml HIV-1 RNA

  at weeks 4, 8, 12, 16, 24, 32, 40, and 48

• Change From Baseline CD4 Counts

  at weeks 4, 8, 12, 16, 24, 32, 40, and 48

• Time to Virologic Failure.

  Week 48

Study Arms (1)

Once daily

EXPERIMENTAL

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

Drug: Once daily

Interventions

Once daily DRUG

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

Also known as: Kaletra, Viread

Once daily

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Oklahoma State University Center for Health Sciences: lead
• Abbott: collaborator

Study Sites (1)

OSU Internal Medicine Specialty Clinic

Tulsa, Oklahoma, 74127, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

lopinavir-ritonavir drug combination; Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Johnny Stephens
• Organization: Oklahoma State University Center for Health Sciences

johnny.stephens@okstate.edu

918-382-3527

Study Officials

• Damon Baker, D.O.

  Oklahoma State University Center for Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: May 19, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: December 4, 2020
• Results First Posted: December 4, 2020

Record last verified: 2020-12

Locations

US (1)