Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors (DVD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cal Cohen, Community Research Initiative of New England
ClinicalTrials.gov Identifier:
NCT00543101
First received: October 11, 2007
Last updated: February 9, 2012
Last verified: February 2012
Results First Received: April 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Darunavir (DRV/r)
Drug: continue on current dual boosted PI

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Five multicenter sites were used these included medical and research clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Switch to DRV/r Switch to DRV/r at a dose of 600/100 BID for 48 weeks
Continue on Current Dual Boosted PI This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.

Participant Flow:   Overall Study
    Switch to DRV/r     Continue on Current Dual Boosted PI  
STARTED     12     12  
COMPLETED     12     12  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Switch to DRV/r Switch to DRV/r at a dose of 600/100 BID for 48 weeks
Continue on Current Dual Boosted PI This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
Total Total of all reporting groups

Baseline Measures
    Switch to DRV/r     Continue on Current Dual Boosted PI     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     12     24  
>=65 years     0     0     0  
Age  
[units: years]
Median ( Full Range )
  46  
  ( 31 to 59 )  
  51  
  ( 36 to 64 )  
  50  
  ( 31 to 64 )  
Gender  
[units: participants]
     
Female     3     2     5  
Male     9     10     19  
Region of Enrollment  
[units: participants]
     
United States     12     12     24  



  Outcome Measures
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1.  Primary:   The Percentage of Participants With Successful Virologic Suppression   [ Time Frame: 24 weeks ]

2.  Secondary:   Economic Impact of a Substitution of Dual Boosted PIs With DRV/r   [ Time Frame: 48 weeks ]

3.  Secondary:   Lipid Fraction Results, Mean of the Change From Baseline to Week 24.   [ Time Frame: baseline and 24 weeks ]

4.  Secondary:   Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now)   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Adverse events data were collected over the course of the study (about 2 years)
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Switch to DRV/r Switch to DRV/r at a dose of 600/100 BID for 48 weeks
Continue on Current Dual Boosted PI This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.

Other Adverse Events
    Switch to DRV/r     Continue on Current Dual Boosted PI  
Total, other (not including serious) adverse events      
# participants affected / at risk     7/12     11/12  
Cardiac disorders      
chest pain      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
Ear and labyrinth disorders      
earache      
# participants affected / at risk     2/12 (16.67%)     0/12 (0.00%)  
# events     2     0  
Eye disorders      
eye irritation      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
Gastrointestinal disorders      
diarrhea      
# participants affected / at risk     1/12 (8.33%)     2/12 (16.67%)  
# events     1     2  
abdominal pain      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
nausea      
# participants affected / at risk     1/12 (8.33%)     1/12 (8.33%)  
# events     1     1  
General disorders      
cough      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
dental      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
malaise      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
body aches      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
fatigue      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
insomnia      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
Hepatobiliary disorders      
abnormal liver function test      
# participants affected / at risk     4/12 (33.33%)     4/12 (33.33%)  
# events     6     5  
Immune system disorders      
bilateral inguinal lymphadeopathy      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
lymphadenopathy      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
Infections and infestations      
flu      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
left molar abscess      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
worsening hepatitis B      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
abscess posterior right thigh      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
herpes glands penis      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
herpes simplex UPNI (HSV) on face      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
herpes zoster      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
neuropathic symptoms      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
periodontal disease      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
respiratory infection      
# participants affected / at risk     2/12 (16.67%)     1/12 (8.33%)  
# events     2     2  
sore throat      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
suprapubic abscess      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
viral syndrome      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     2  
Metabolism and nutrition disorders      
gout      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
elevated cholesterol      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
elevated glucose      
# participants affected / at risk     1/12 (8.33%)     1/12 (8.33%)  
# events     2     1  
elevated triglycerides      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
Musculoskeletal and connective tissue disorders      
chest pain      
# participants affected / at risk     1/12 (8.33%)     1/12 (8.33%)  
# events     1     1  
decreased range of motion, left shoulder/arm      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
fractured sternum      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
lower back pain      
# participants affected / at risk     0/12 (0.00%)     2/12 (16.67%)  
# events     0     2  
neck pain      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
nose fracture      
# participants affected / at risk     1/12 (8.33%)     1/12 (8.33%)  
# events     1     1  
right arm pain (secondary to motor vehicle accident)      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
right hip pain (secondary to motor vehicle accident)      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
right knee pain (secondary to motor vehicle accident)      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
body aches      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
broken wrist      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
pulled hamstring      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
wrist sprain      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
recurrence of squamous cell carcinoma in situ-colorectal      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
Nervous system disorders      
intermittent tingling on tongue with metallic taste      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
intermittent numbness left face/tongue      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
intermittent numbness left face/tongue      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
symptoms of memory loss      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
meralgia paresthetica      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
Psychiatric disorders      
depression      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
Renal and urinary disorders      
creatinine      
# participants affected / at risk     1/12 (8.33%)     1/12 (8.33%)  
# events     1     2  
Respiratory, thoracic and mediastinal disorders      
bronchitis      
# participants affected / at risk     2/12 (16.67%)     0/12 (0.00%)  
# events     2     0  
coarse rhonchi bilaterally      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
nasal congestion      
# participants affected / at risk     3/12 (25.00%)     2/12 (16.67%)  
# events     3     3  
asthmatic, bronchitis      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
Skin and subcutaneous tissue disorders      
anal ulceration      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
pubic region      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
anal fissure      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
cellulitis      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
contusion, right forehead      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
inflammation penis      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
open wound, finger      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
pruritis      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
sebaceous cyst      
# participants affected / at risk     0/12 (0.00%)     1/12 (8.33%)  
# events     0     1  
skin rash      
# participants affected / at risk     2/12 (16.67%)     2/12 (16.67%)  
# events     2     2  
Vascular disorders      
bilateral ankle and pedal edema      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
elevated blood pressure, intermittent      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
worsening hypertension      
# participants affected / at risk     1/12 (8.33%)     0/12 (0.00%)  
# events     1     0  
headache      
# participants affected / at risk     1/12 (8.33%)     1/12 (8.33%)  
# events     1     1  



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The foremost problem was the small number of participants enrolled. By the time we were open for enrollment, most clinicians in the community had already switched their patients from dual boosted regimens to darunavir/ritonavir.


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