DRIVESHAFT: Darunavir/Ritonavir In HIV-infected Virologically-suppressed Experienced Subjects (DRIVESHAFT)
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ClinicalTrials.gov Identifier: NCT01423812 |
Recruitment Status
:
Completed
First Posted
: August 26, 2011
Results First Posted
: February 7, 2018
Last Update Posted
: February 7, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: Twice-daily Darunavir and ritonavir Drug: Once-daily Darunavir and ritonavir | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | DRIVESHAFT : Darunavir/Ritonavir In Virologically-suppressed Experienced Subjects Halving an Antiretroviral by Finetuning Therapy - A Phase IV Randomized, Open-Label Study to Evaluate in HIV-1 Infected , Virologically-suppressed Patients on Regimens With Darunavir 600mg/ Ritonavir 100mg Twice-daily Switching to Darunavir 800mg/ Ritonavir 100mg Once-daily Versus Continuing Darunavir 600mg/ Ritonavir 100mg Twice-daily Containing Regimens |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | April 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Once-daily Darunavir and ritonavir
Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily
|
Drug: Once-daily Darunavir and ritonavir
Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks
|
Active Comparator: Twice-daily Darunavir and ritonavir
Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
|
Drug: Twice-daily Darunavir and ritonavir
Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
|
- Primary Efficacy Endpoint for Virologic Suppression in HIV-infected Subjects [ Time Frame: 48 weeks after randomization to study medication ]Proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 48 using a Missing, Switch, or Discontinuation = Failure (MSDF) algorithm as codified by the FDA's "snapshot" algorithm
- Secondary Efficacy Endpoints [ Time Frame: Within 48 weeks after randomization to study medication ]
- Proportion of subjects with plasma HIV-1 RNA <50 c/mL and <400 c/mL at Week 24
- Proportion of subjects with plasma HIV-1 RNA <400 c/mL at Week 48
- Safety Assessment [ Time Frame: Within 48 weeks of randomization to study medications ]•Compare the tolerability, safety, and change in lipid parameters(total cholesterol, LDL, HDL, triglycerides) of once-daily versus twice-daily darunavir/ritonavir containing regimens over 48 weeks
- Immunologic Endpoints [ Time Frame: 48 weeks after randomization to study medications ]•Absolute values and changes from baseline in CD4+ and CD8+ over time
- Assessment of Virologic Failure [ Time Frame: Within 48 weeks of randomization to study medications ]•Assess the development of viral resistance in subjects experiencing virological failure
- Medication Adherence Assessment [ Time Frame: Within 48 weeks of randomization to study medications ]Characterize adherence to once-daily versus twice-daily darunavir/ritonavir containing regimens using the Modified Medication Adherence Self-Report Inventory (M-MASRI) scale
- Secondary Efficacy Endpoints [ Time Frame: week 24 ]•Proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 24

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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:
- ART-experienced, HIV-1 infected subjects ≥18 years of age.
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A female subject is eligible to enter and participate in the study if she:
- is of non-childbearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy, or bilateral oophorectomy or,
-
is of child-bearing potential, with a negative pregnancy test at both Screen and Day 1 and agrees to one of the following methods of contraception to avoid pregnancy:
- Complete abstinence from intercourse from 2 weeks prior to administration of study medications, throughout the study, and for at least 2 weeks after discontinuation of all study medications.
- Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide).
- Approved hormonal contraception may be administered with darunavir/ritonavir
- Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year
- Any other method with published data showing that the expected failure rate is <1% per year.
Any contraception method must be used consistently and in accordance with the approved product label. All subjects participating in the study should be counseled on safer sexual practices including the use of effective barrier methods (e.g. male condom/spermicide).
- CD4 >50 cells/mm3
- HIV-1 RNA concentrations at undetectable levels (according to local assay being used) for at least 12 weeks on stable current regimen
- Current regimen includes darunavir/ritonavir 600/100 mg twice-daily plus a minimum of two other antiretrovirals
- Negative serum pregnancy test at screening visit
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
- Known hypersensitivity reaction to agents being utilized in the study
- >1 cumulative darunavir associated mutations (V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V, or L89V) detected from any previous genotype or a VircoTYPE HIV-1 darunavir fold-change >10.0 on any previous virtual phenotype
- Pregnant or breast feeding woman
- Liver dysfunction with Child-Pugh class C disease or decompensated cirrhosis

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): NCT01423812
United States, Illinois | |
Ruth M. Rothstein CORE Center | |
Chicago, Illinois, United States, 60612 |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Gregory Huhn, Attending Physician, Ruth M. Rothstein CORE Center |
ClinicalTrials.gov Identifier: | NCT01423812 History of Changes |
Other Study ID Numbers: |
TMC114HIV4063 |
First Posted: | August 26, 2011 Key Record Dates |
Results First Posted: | February 7, 2018 |
Last Update Posted: | February 7, 2018 |
Last Verified: | January 2018 |
Keywords provided by Gregory Huhn, Ruth M. Rothstein CORE Center:
HIV treatment-experienced protease inhibitor adherence lipids |
Additional relevant MeSH terms:
Ritonavir Darunavir 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 |