NCT00677300

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for phase_4 hiv-infections

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4 hiv-infections

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 8, 2014

Status Verified

September 1, 2014

Enrollment Period

3.8 years

First QC Date

May 8, 2008

Last Update Submit

September 5, 2014

Conditions

HIV Infections

Keywords

HIVTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • 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)

    Week 24

Secondary Outcomes (4)

  • Median change in CD4 count from baseline

    48 Weeks

  • Percentage of patients with treatment-emergent fasting hypertriglyceridemia (TG >400) or hypercholesterolemia (TC >240)

    48 weeks

  • Median change in limb fat from baseline, by DEXA scan

    48 weeks

  • Changes from baseline in insulin resistance measured by homeostasis model assessment (HOMA-IR)

    48 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Will receive Raltegravir (400mg twice daily) + Ritonavir-boosted (100mg once daily) Darunavir (800mg once daily)

Drug: RaltegravirDrug: DarunavirDrug: Ritonavir

Group B

ACTIVE COMPARATOR

Will receive Tenofovir (300mg once daily) + Emtricitabine (200mg once daily) + Ritonavir-boosted (100mg once daily) Darunavir (800mg once daily)

Drug: DarunavirDrug: RitonavirDrug: Tenofovir/Emtricitabine

Interventions

RaltegravirDRUG

400mg P.O. (orally) twice daily for 48 weeks

Also known as: Isentris
Group A
DarunavirDRUG

800 mg P.O. (orally) once daily

Also known as: Prezista
Group AGroup B
RitonavirDRUG

100mg once daily

Also known as: Norvir
Group AGroup B
Tenofovir/EmtricitabineDRUG

300 mg/200 mg P.O. (orally) once daily

Also known as: Truvada
Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Parkland Health & Hospital System

Dallas, Texas, 75390, United States

Location

Related Publications (1)

  • Bedimo RJ, Drechsler H, Jain M, Cutrell J, Zhang S, Li X, Farukhi I, Castanon R, Tebas P, Maalouf NM. The RADAR study: week 48 safety and efficacy of RAltegravir combined with boosted DARunavir compared to tenofovir/emtricitabine combined with boosted darunavir in antiretroviral-naive patients. Impact on bone health. PLoS One. 2014 Aug 29;9(8):e106221. doi: 10.1371/journal.pone.0106221. eCollection 2014.

    PMID: 25170938DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir PotassiumDarunavirRitonavirTenofovirEmtricitabineEmtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSulfonamidesAmidesOrganic ChemicalsCarbamatesAcids, AcyclicCarboxylic AcidsSulfonesSulfur CompoundsFuransThiazolesAzolesOrganophosphonatesOrganophosphorus CompoundsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Roger Bedimo, M.D.

    Dallas VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ID Section Chief

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 14, 2008

Study Start

January 1, 2009

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

September 8, 2014

Record last verified: 2014-09

Locations

US(2)