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Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL) (PROGRESS)
This study is ongoing, but not recruiting participants.
First Received: July 3, 2008   Last Updated: April 29, 2009   History of Changes
Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00711009
  Purpose

The purpose of this study is to compare the safety, tolerability and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with an HIV-1 integrase inhibitor in antiretroviral naive HIV-1 infected subjects.


Condition Intervention Phase
HIV Infection
Drug: lopinavir/ritonavir (LPV/r)
Drug: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
Drug: raltegravir (RAL)
Phase III

MedlinePlus related topics: AIDS
Drug Information available for: Tenofovir Ritonavir Lopinavir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Raltegravir
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
Official Title: A Randomized, Open-Label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-Formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily in Antiretroviral Naive, HIV-1 Infected Subjects

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Proportion of subjects responding with plasma HIV-1 RNA levels < 40 copies/mL. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • To compare the safety and tolerability of subjects in each treatment arm. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of subjects with HIV-1 RNA levels < 40 copies/mL at each visit, mean change from baseline in CD4+T cell counts to each visit, time to virologic response, incidence of resistance to each drug in the study regimen. [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Analysis of patient reported outcomes. [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring. Somatic Toxicity - Full-body DEXA scan and anthropometric measurements for fat redistribution. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Metabolic Toxicity - fasted glucose, insulin, lipid measurements (total cholesterol, triglycerides, LDL and HDL), and exploratory markers (lactate, adiponectin, IL-6, leptin, soluble serum TNF receptors I and II. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 206
Study Start Date: July 2008
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
LPV/r + FTC/TDF: Active Comparator Drug: lopinavir/ritonavir (LPV/r)
LPV/r 400/100 mg BID
Drug: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
FTC/TDF 200/300 mg QD
LPV/r + RAL: Experimental Drug: lopinavir/ritonavir (LPV/r)
LPV/r 400/100 mg BID
Drug: raltegravir (RAL)
RAL 400 mg BID

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must provide written, voluntary informed consent to participate in the study.
  • Subjects must be naive to antiretroviral treatment with HIV RNA greater than or equal to 1,000 copies/mL at screening, and in the investigator's opinion, require antiretroviral therapy.
  • Subject's vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
  • Subject has not been treated for an active AIDS-defining opportunistic infection within 45 days of initiating study drug. Subjects who are on stable maintenance therapy for an opportunistic infection may be enrolled after consultation with Sponsor.
  • Subject does not require and agrees not to take any drugs that are contraindicated or have significant pharmacokinetic interactions with study drugs during the course of the study. Subject agrees not to take any medication during the study, including over-the-counter medicines, vitamins, minerals, herbal preparations, alcohol or recreational drugs, without the knowledge and permission of the principal investigator.
  • Female subjects must be either postmenopausal for at least one year, surgically sterile, or must use a non-hormonal method of birth control that is acceptable to both the subject and investigator. All female subjects must have a urine pregnancy test performed at screening visit and on day
  • 1/baseline, and results of both tests must be negative. Female subjects may not be breastfeeding.
  • Subjects have received no prior treatment with an HIV-1 integrase inhibitor.

Exclusion Criteria:

  • Subjects must not have history of an allergic reaction or significant sensitivity to the study drugs.
  • Subjects may not have an ongoing history of substance abuse or psychiatric illness that could preclude protocol adherence.
  • Subject cannot have resistance to lopinavir/ritonavir, tenofovir or emtricitabine based on the HIV-1 drug resistance genotypic test results at the screening visit.
  • Subject may not have significant medical history of concomitant illness or disease that would adversely affect his/her participating in the study.
  • Subjects may not have received any investigational drug or investigational vaccine within 30 days prior to study drug administration.
  • Subjects may not have any of the following abnormal screening results: Hemoglobin <= 8.0 G/dL, absolute neutrophil count <= 750 cells/mcl/mL, Platelet count <= 50,000 per mL, ALT (SGPT) or AST (SGOT) >= 3.0 x upper limit of normal (ULN), calculated creatinine clearance < 50 mL/min, Hepatitis B surface antigen HBsAG is positive.
  • The investigator considers the subject to be an unsuitable candidate for the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711009

Locations
United States, Illinois
Global Medical Information
Abbott Park, Illinois, United States, 60064
Sponsors and Collaborators
Abbott
Investigators
Study Director: Adebayo A Lawal, MD MSc Abbott
  More Information

No publications provided

Responsible Party: Abbott ( Barry Bernstein, MD, Global Project Head )
Study ID Numbers: M10-336
Study First Received: July 3, 2008
Last Updated: April 29, 2009
ClinicalTrials.gov Identifier: NCT00711009     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
Emtricitabine
Lopinavir
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Tenofovir
Retroviridae Infections
Tenofovir disoproxil

Additional relevant MeSH terms:
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Lopinavir
Emtricitabine
Anti-Retroviral Agents
Therapeutic Uses
Tenofovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil
RNA Virus Infections
HIV Protease Inhibitors
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on May 07, 2009