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Raltegravir And Darunavir Antiretroviral in Antiretroviral Naive Patients (RADAR)
This study is not yet open for participant recruitment.
Verified by Dallas VA Medical Center, May 2008
Sponsors and Collaborators: Dallas VA Medical Center
Funded by academic grant from Merck & Co, Inc.
Tibotec Pharmaceutical Limited
Information provided by: Dallas VA Medical Center
ClinicalTrials.gov Identifier: NCT00677300
  Purpose

The purpose of this study is to determine whether a combination of raltegravir and darunavir is as effective as standard regimens in the treatment of HIV-infected patients who have not previously used antiretroviral drug (treatment naive)


Condition Intervention Phase
HIV Infections
Drug: Raltegravir
Drug: Darunavir
Drug: Ritonavir
Drug: Tenofovir/Emtricitabine
Phase IV

MedlinePlus related topics: AIDS
Drug Information available for: Ritonavir Darunavir Darunavir ethanolate Raltegravir Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Truvada
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Evaluation of Safety and Efficacy of Raltegravir/Darunavir Combination in Antiretroviral-Naive Patients

Further study details as provided by Dallas VA Medical Center:

Primary Outcome Measures:
  • Time from randomization to virologic failure (HIV viral load of 1,000 copies/ml or greater at or after Week 16 and before Week 24, or two consecutive HIV viral load of 50 copies/ml or greater at or after Week 24) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median change in CD4 count from baseline [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with treatment-emergent fasting hypertriglyceridemia (TG >400) or hypercholesterolemia (TC >240) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Median change in limb fat from baseline, by DEXA scan [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Changes from baseline in insulin resistance measured by homeostasis model assessment (HOMA-IR) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: June 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A: Experimental
Will receive Raltegravir (400mg twice daily) + Ritonavir-boosted (100mg once daily) Darunavir (800mg once daily)
Drug: Raltegravir
400mg P.O. (orally) twice daily for 48 weeks
Drug: Darunavir
800 mg P.O. (orally) once daily
Drug: Ritonavir
100mg once daily
Group B: Active Comparator
Will receive Tenofovir (300mg once daily) + Emtricitabine (200mg once daily) + Ritonavir-boosted (100mg once daily) Darunavir (800mg once daily)
Drug: Darunavir
800 mg P.O. (orally) once daily
Drug: Ritonavir
100mg once daily
Drug: Tenofovir/Emtricitabine
300 mg/200 mg P.O. (orally) once daily

  Show Detailed Description

  Eligibility

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

Inclusion Criteria

  • The patient has documented HIV-1 infection.
  • The patient is at least 18 years of age.
  • Antiretroviral naive, defined as 7 days or less of ARV treatment at any time prior to study entry. HIV viral load greater than 5,000 copies/ml within 90 days of study entry
  • CD4 count is greater than 100/ml within 90 days of study entry
  • Willing to use acceptable forms of contraception
  • Parent or guardian willing to provide informed consent, if applicable
  • Hepatitis B surface antigen (HBsAg) negative at study entry

Exclusion Criteria

  • Patient is current participant in a Raltegravir trial or in trials involving any of the other study medications (Darunavir, Tenofovir or Emtricitabine).
  • Immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry. Individuals receiving either stable physiologic glucocorticoid doses, corticosteroids for acute therapy for pneumocystis pneumonia, or a short course (2 weeks or less) of pharmacologic glucocorticoid therapy will not be excluded.
  • Known allergy/sensitivity to study drugs or their formulations
  • Patient has a condition (including but not limited to active alcohol or drug use) that, in the opinion of the investigator, may interfere with patient adherence or safety
  • Patient with acute hepatitis due to any cause or clinically significant chronic liver disease including but not limited to cirrhosis, ascites, encephalopathy, hypoalbuminemia, prolonged PT/PTT and/or esophageal varices.
  • Patient has severe renal insufficiency defined as a calculated creatinine clearance at time of screening <30 mL/min, base on Cockcroft/Gault equation which is as follows (and 0.85 X this value for females):
  • CrCl (mL/min) = [(140-Age) x Weight (in Kg)]/72 x Serum Creatinine (mg/mL)
  • Serious illness requiring systemic treatment or hospitalization. Patients who have completed therapy or are clinically stable on therapy for at least 7 days prior to study entry are not excluded.
  • Known clinically relevant cardiac conduction system disease
  • Patient requires or is anticipated to require any of the prohibited medications noted in the protocol
  • Current imprisonment or involuntary incarceration for psychiatric or physical (e.g., infectious disease) illness
  • Pregnancy and Breastfeeding. Women who become pregnant during the study will be required to permanently discontinue their study regimens.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00677300

Contacts
Contact: Roger Bedimo, M.D. 214-857-0410 roger.bedimo@va.gov
Contact: Holly A Wise 214-857-1415 holly.wise@va.gov

Locations
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Dallas VA Medical Center
Funded by academic grant from Merck & Co, Inc.
Tibotec Pharmaceutical Limited
Investigators
Principal Investigator: Roger Bedimo, M.D. Dallas VA Medical Center
  More Information

Responsible Party: VA North Texas Health Care System ( Roger Bedimo, M.D. - Chief, Infectious Diseases )
Study ID Numbers: Merck 072-00
Study First Received: May 8, 2008
Last Updated: June 4, 2008
ClinicalTrials.gov Identifier: NCT00677300  
Health Authority: United States: Federal Government

Keywords provided by Dallas VA Medical Center:
HIV
Treatment Naive

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Emtricitabine
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Tenofovir
Retroviridae Infections
Darunavir
Immunologic Deficiency Syndromes
Tenofovir disoproxil

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 14, 2009