Raltegravir And Darunavir Antiretroviral in Antiretroviral Naive Patients (RADAR)
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ClinicalTrials.gov Identifier: NCT00677300 |
Recruitment Status
:
Completed
First Posted
: May 14, 2008
Last Update Posted
: September 8, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Raltegravir Drug: Darunavir Drug: Ritonavir Drug: Tenofovir/Emtricitabine | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 85 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Safety and Efficacy of Raltegravir/Darunavir Combination in Antiretroviral-Naive Patients |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Group A
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
Other Name: Isentris
Drug: Darunavir
800 mg P.O. (orally) once daily
Other Name: Prezista
Drug: Ritonavir
100mg once daily
Other Name: Norvir
|
Active Comparator: Group B
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
Other Name: Prezista
Drug: Ritonavir
100mg once daily
Other Name: Norvir
Drug: Tenofovir/Emtricitabine
300 mg/200 mg P.O. (orally) once daily
Other Name: Truvada
|
- 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 ]
- Median change in CD4 count from baseline [ Time Frame: 48 Weeks ]
- Percentage of patients with treatment-emergent fasting hypertriglyceridemia (TG >400) or hypercholesterolemia (TC >240) [ Time Frame: 48 weeks ]
- Median change in limb fat from baseline, by DEXA scan [ Time Frame: 48 weeks ]
- Changes from baseline in insulin resistance measured by homeostasis model assessment (HOMA-IR) [ Time Frame: 48 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677300
United States, Texas | |
Dallas VA Medical Center | |
Dallas, Texas, United States, 75216 | |
Parkland Health & Hospital System | |
Dallas, Texas, United States, 75390 |
Principal Investigator: | Roger Bedimo, M.D. | Dallas VA Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Roger Bedimo, M.D., ID Section Chief, Dallas VA Medical Center |
ClinicalTrials.gov Identifier: | NCT00677300 History of Changes |
Other Study ID Numbers: |
Merck 072-00 |
First Posted: | May 14, 2008 Key Record Dates |
Last Update Posted: | September 8, 2014 |
Last Verified: | September 2014 |
Keywords provided by Roger Bedimo, M.D., Dallas VA Medical Center:
HIV Treatment Naive |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Darunavir Tenofovir Raltegravir Potassium Emtricitabine |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors HIV Integrase Inhibitors Integrase Inhibitors |