A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients (INROADS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01199939 |
Recruitment Status
:
Completed
First Posted
: September 13, 2010
Results First Posted
: December 4, 2013
Last Update Posted
: December 4, 2013
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Immunodeficiency Virus (HIV) | Drug: Etravirine Drug: Ritonavir Drug: Darunavir | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Single Arm, Open-Label Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | October 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: ETR + DRV/rtv
Darunavir 800mg once daily orally for 48 weeks,Etravirine 400mg once daily orally for 48 weeks,Ritonavir 100mg once daily orally for 48 weeks
|
Drug: Etravirine
400mg once daily orally for 48 weeks
Drug: Ritonavir
100mg once daily orally for 48 weeks
Drug: Darunavir
800mg once daily orally for 48 weeks
|
- Number of Participants With Confirmed Virologic Response (CVR) at Week 48 [ Time Frame: Week 48 ]CVR is defined as confirmed plasma Viral Load of less than 50 human immunodeficiency virus - type 1 (HIV-1) ribonucleic acid (RNA) copies/mL.
- Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 4 [ Time Frame: Baseline (Day 1) and Week 4 ]
- Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 8 [ Time Frame: Baseline (Day 1) and Week 8 ]
- Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]
- Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 16 [ Time Frame: Baseline (Day 1) and Week 16 ]
- Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 20 [ Time Frame: Baseline (Day 1) and Week 20 ]
- Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 24 [ Time Frame: Baseline (Day 1) and Week 24 ]
- Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 30 [ Time Frame: Baseline (Day 1) and Week 30 ]
- Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 36 [ Time Frame: Baseline (Day 1) and Week 36 ]
- Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 42 [ Time Frame: Baseline (Day 1) and Week 42 ]
- Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 48 [ Time Frame: Baseline (Day 1) and Week 48 ]
- Time to Reach First Confirmed Virologic Response [ Time Frame: Baseline (Day 1) to Week 48 ]CVR is defined as confirmed plasma Viral Load of less than 50 human immunodeficiency virus - type 1 (HIV-1) ribonucleic acid (RNA) copies/mL.
- Number of Participants With Virologic Failure [ Time Frame: Baseline (Day 1) to Week 48 ]Virologic Failure is defined as participant who is a rebounder or a non-responder. Rebounder participant is defined as a participant who is still in the study at Week 12 and first achieves 2 consecutive virologic responses (<50 copies/mL) followed by 2 consecutive non-responses or a discontinued participant (any reason) for which the last observed time point shows a non-response. Non responder participant is defined as a participant who is still in the study at Week 12 and never achieves 2 consecutive responses.
- Change From Baseline in Cluster of Differentiation 4 (CD4+) and Cluster of Differentiation 8 (CD8+) Cell Counts at Week 48 [ Time Frame: Baseline (Day 1) and Week 48 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female patients, aged 18 years or above
- Patients with documented HIV-1 infection
- On current HAART regimen for at least 12 weeks continuous duration at screening, and with an HIV-1 plasma viral load above 500 HIV-1 RNA copies/mL by site's currently utilized viral load assay (Note: For the purposes of this study, HAART is defined as treatment with a combination of 3 or more HIV antiretroviral medications from at least 2 different classes of medications (NRTIs, NNRTIs, PIs, integrase inhibitors, CCR5 antagonists, fusion inhibitors))
- No more than 2 previous virologic failures while on PI-containing HAART regimens where virologic failure is generally defined as either a lack of suppression of the subjects' viral load to lower limit of quantification (per standard assay historically used in care) after 24 weeks of treatment or, rebound of a previously suppressed viral load (undetectable per investigator's standard of care) to detectable limits and without demonstrated re-suppression on the same regimen
- Demonstrated phenotypic sensitivity to both etravirine and darunavir based on resistance testing at Screening (FC= 2.9 for etravirine and FC = 10.0 for darunavir using the PhenoSense GT)
- The absence of all of the following Resistance Associated Mutations (RAMS) at baseline: For Darunavir: V11I, V32I, L33F, I47V, I50V, I54L/M, T74P, L76V, I84V, L89V
- For Etravirine: L100I, E138A, I167V, V179D, V179F, Y181I, Y181V, G190S
- 7. CD4 count = 50 cells/mm3.
Exclusion Criteria:
- Primary HIV-1 infection
- Previously documented HIV-2 infection
- Use of disallowed concomitant therapy
Any condition (including but not limited to alcohol and drug use), which, in the opinion of the investigator, could compromise the patient's safety or adherence to the protocol
- Life expectancy less than 6 months according to the judgment of the investigator
- Patient has any currently active AIDS defining illness (Category C conditions according to the Center for Disease Control [CDC] Classification System for HIV infection 1993
- with the following exceptions, which must be discussed with the sponsor prior to enrollment: Stable cutaneous Kaposi's Sarcoma (i.e., no pulmonary or gastrointestinal involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the trial period
- Wasting syndrome due to HIV infection if, in the investigator's opinion, it is not actively progressive and its treatment does not require hospitalization or compromise the patient's safety or compliance to adhere to trial-related procedures. If the patient is on maintenance therapy (which may include Growth Hormone, appetite stimulants and anabolic steroids) for previously diagnosed wasting syndrome, he/she may be eligible for the trial. Note: An AIDS defining illness not clinically stabilized for at least 30 days will be considered clinically active. Note: Primary and secondary prophylaxis for an AIDS defining illness is allowed in case the medication used is not part of the disallowed medications
- Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings during screening of medical history, laboratory or physical examination that, in the investigator's opinion, would compromise the patient's safety or the outcome of the trial.

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): NCT01199939
United States, California | |
Long Beach, California, United States | |
Los Angeles, California, United States | |
San Francisco, California, United States | |
United States, Colorado | |
Denver, Colorado, United States | |
United States, District of Columbia | |
Washington, District of Columbia, United States | |
United States, Florida | |
Fort Pierce, Florida, United States | |
Miami, Florida, United States | |
Orlando, Florida, United States | |
United States, Georgia | |
Decatur, Georgia, United States | |
Macon, Georgia, United States | |
United States, Michigan | |
Berkley, Michigan, United States | |
United States, Missouri | |
Saint Louis, Missouri, United States | |
United States, New Jersey | |
Hillsborough, New Jersey, United States | |
Neptune, New Jersey, United States | |
United States, New York | |
Buffalo, New York, United States | |
Manhasset, New York, United States | |
United States, North Carolina | |
Charlotte, North Carolina, United States | |
United States, Texas | |
Austin, Texas, United States | |
Dallas, Texas, United States | |
Harlingen, Texas, United States | |
Houston, Texas, United States | |
United States, Washington | |
Seattle, Washington, United States | |
Puerto Rico | |
San Juan, Puerto Rico |
Study Director: | Tibotec, Inc. Clinical Trial | Tibotec, Inc |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Tibotec, Inc |
ClinicalTrials.gov Identifier: | NCT01199939 History of Changes |
Other Study ID Numbers: |
CR017149 TMC125HIV4007 ( Other Identifier: Tibotec, Inc. ) |
First Posted: | September 13, 2010 Key Record Dates |
Results First Posted: | December 4, 2013 |
Last Update Posted: | December 4, 2013 |
Last Verified: | October 2013 |
Keywords provided by Tibotec, Inc:
Human Immunodeficiency Virus HIV Etravirine Darunavir |
Prezista Intelence Ritonavir INROADS |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Ritonavir Darunavir |
Etravirine 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 |