ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study of a Raltegravir Based NRTI Sparing Regimen

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: NCT00814879
Recruitment Status : Completed
First Posted : December 25, 2008
Results First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Sponsor:
Collaborators:
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acquired Immune Deficiency Syndrome
AIDS
Human Immunodeficiency Virus
HIV Infections
Interventions Drug: Raltegravir
Drug: Atazanavir
Other: Standard treatment regimen
Enrollment 60
Recruitment Details A total of 60 patients were randomized in this pilot study; 30 in each arm. Two patients randomized to stay on their N(t)NRTIs+PIr regimen were randomization failures as the patients did not for return for their baseline visit.
Pre-assignment Details  
Arm/Group Title N(t)RTI(s) + PI/r RAL + ATV
Hide Arm/Group Description

N(t)RTI(s) based backbone & PI/r

Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI

Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID

Raltegravir: 400 mg BID

Atazanavir: 300 mg BID

Period Title: By Week 24
Started 28 30
Completed 27 29
Not Completed 1 1
Reason Not Completed
Cancer Diagnosis             1             0
Incarceration             0             1
Period Title: By Week 48
Started 27 29
Completed 25 26
Not Completed 2 3
Reason Not Completed
Lost to Follow-up             2             2
Death             0             1
Arm/Group Title N(t)NRTI + Plr RAL + ATV Total
Hide Arm/Group Description

N(t)RTI(s) based backbone & PI/r

Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI

Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID

Raltegravir: 400 mg BID

Atazanavir: 300 mg BID

Total of all reporting groups
Overall Number of Baseline Participants 28 30 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 30 participants 58 participants
48.5  (9.8) 48.0  (9.7) 48.2  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 participants
Female
5
  17.9%
6
  20.0%
11
  19.0%
Male
23
  82.1%
24
  80.0%
47
  81.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 participants
American Indian or Alaska Native
1
   3.6%
0
   0.0%
1
   1.7%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  21.4%
9
  30.0%
15
  25.9%
White
21
  75.0%
20
  66.7%
41
  70.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   3.3%
1
   1.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 30 participants 58 participants
28 30 58
1.Primary Outcome
Title Number of Patients Reaching Virologic Failure at Week 48.
Hide Description Virologic failure was defined by protocol as a plasma HIV RNA >50 c/mL on 2 consecutive occasions >7 days apart or > 10 000 c/mL on one occasion (in the absence of an intercurrent infection or recent immunization).
Time Frame 48 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N(t)RTI(s) + PI/r RAL + ATV
Hide Arm/Group Description:

N(t)RTI(s) based backbone & PI/r

Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI

Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID

Raltegravir: 400 mg BID

Atazanavir: 300 mg BID

Overall Number of Participants Analyzed 25 26
Measure Type: Number
Unit of Measure: participants
2 3
2.Secondary Outcome
Title Number of Patients With < 400 Copies HIV RNA/mL at Week 48
Hide Description [Not Specified]
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N(t)RTI(s) + PI/r RAL + ATV
Hide Arm/Group Description:

N(t)RTI(s) based backbone & PI/r

Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI

Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID

Raltegravir: 400 mg BID

Atazanavir: 300 mg BID

Overall Number of Participants Analyzed 25 26
Measure Type: Number
Unit of Measure: participants
22 21
3.Secondary Outcome
Title CD4+ Cell Count
Hide Description [Not Specified]
Time Frame Weeks 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N(t)NRTI + Plr RAL + ATV
Hide Arm/Group Description:

N(t)RTI(s) based backbone & PI/r

Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI

Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID

Raltegravir: 400 mg BID

Atazanavir: 300 mg BID

Overall Number of Participants Analyzed 27 29
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
599.4  (276.1) 710.0  (37.80)
4.Secondary Outcome
Title CD4+ Cell Count
Hide Description [Not Specified]
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N(t)RTI(s) + PI/r RAL + ATV
Hide Arm/Group Description:

N(t)RTI(s) based backbone & PI/r

Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI

Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID

Raltegravir: 400 mg BID

Atazanavir: 300 mg BID

Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
596.6  (289.1) 665.9  (365.4)
5.Secondary Outcome
Title Cholesterol
Hide Description Total cholersterol (mg/dL)
Time Frame baseline, week 24, week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N(t)RTI(s) + PI/r RAL + ATV
Hide Arm/Group Description:

N(t)RTI(s) based backbone & PI/r

Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI

Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID

Raltegravir: 400 mg BID

Atazanavir: 300 mg BID

Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 166.25  (41.58) 178.83  (46.97)
Week 24 168.07  (43.77) 169.65  (41.39)
Week 48 167.41  (41.19) 174.48  (37.12)
6.Secondary Outcome
Title Mean Change in Total Bilirubin (mg/dL) From Baseline
Hide Description mean change in total bilirubin from baseline
Time Frame baseline and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N(t)RTI(s) + PI/r RAL + ATV
Hide Arm/Group Description:

N(t)RTI(s) based backbone & PI/r

Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI

Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID

Raltegravir: 400 mg BID

Atazanavir: 300 mg BID

Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.15  (0.85) 0.37  (1.39)
Time Frame Adverse events were assesses across the duration of the study through week 48.
Adverse Event Reporting Description Serious adverse events were those that resulted in either hospitalization, death or pregnancy.
 
Arm/Group Title N(t)RTI(s) + PI/r RAL + ATV
Hide Arm/Group Description

N(t)RTI(s) based backbone & PI/r

Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI

Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID

Raltegravir: 400 mg BID

Atazanavir: 300 mg BID

All-Cause Mortality
N(t)RTI(s) + PI/r RAL + ATV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
N(t)RTI(s) + PI/r RAL + ATV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/28 (10.71%)      6/30 (20.00%)    
Endocrine disorders     
Hyperglycemia *  0/28 (0.00%)  0 1/30 (3.33%)  3
Gastrointestinal disorders     
Diarrhea *  0/28 (0.00%)  0 1/30 (3.33%)  1
Mesenteric Panniculitis *  0/28 (0.00%)  0 1/30 (3.33%)  1
Immune system disorders     
Death *  0/28 (0.00%)  0 1/30 (3.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung Cancer *  1/28 (3.57%)  1 0/30 (0.00%)  0
Psychiatric disorders     
Suicidal Ideation *  0/28 (0.00%)  0 1/30 (3.33%)  1
Reproductive system and breast disorders     
Pregnancy *  0/28 (0.00%)  0 1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders     
Aspiration Pneumonia *  0/28 (0.00%)  0 1/30 (3.33%)  2
Skin and subcutaneous tissue disorders     
Cellulitis *  2/28 (7.14%)  2 0/30 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
N(t)RTI(s) + PI/r RAL + ATV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/28 (92.86%)      25/30 (83.33%)    
Gastrointestinal disorders     
Constipation *  0/28 (0.00%)  0 2/30 (6.67%)  2
Diarrhea *  3/28 (10.71%)  3 4/30 (13.33%)  6
GERD *  2/28 (7.14%)  2 0/30 (0.00%)  0
Nausea *  1/28 (3.57%)  1 3/30 (10.00%)  3
Vomiting *  1/28 (3.57%)  1 2/30 (6.67%)  2
General disorders     
Fatigue *  3/28 (10.71%)  3 0/30 (0.00%)  0
Headache *  1/28 (3.57%)  1 3/30 (10.00%)  3
Myalgias *  0/28 (0.00%)  0 1/30 (3.33%)  1
Night Sweats *  1/28 (3.57%)  1 0/30 (0.00%)  0
General Pain *  4/28 (14.29%)  7 3/30 (10.00%)  6
Sinus Congestion *  1/28 (3.57%)  3 1/30 (3.33%)  1
Weight Loss *  1/28 (3.57%)  1 0/30 (0.00%)  0
Other * [1]  24/28 (85.71%)  77 24/30 (80.00%)  90
Infections and infestations     
Fever *  1/28 (3.57%)  1 1/30 (3.33%)  1
Sinusitis *  1/28 (3.57%)  1 1/30 (3.33%)  1
Upper Respiratory Infection *  3/28 (10.71%)  4 3/30 (10.00%)  4
Nervous system disorders     
Dizziness *  0/28 (0.00%)  0 1/30 (3.33%)  1
Psychiatric disorders     
Anxiety *  0/28 (0.00%)  0 4/30 (13.33%)  4
Depression *  0/28 (0.00%)  0 1/30 (3.33%)  1
Renal and urinary disorders     
Urinary Tract Infection *  1/28 (3.57%)  1 2/30 (6.67%)  2
Respiratory, thoracic and mediastinal disorders     
CAP- Community Acquired Pneumonia *  0/28 (0.00%)  0 1/30 (3.33%)  2
Cough *  1/28 (3.57%)  1 0/30 (0.00%)  0
DOE- Dyspnea on Exertion *  1/28 (3.57%)  1 0/30 (0.00%)  0
Skin and subcutaneous tissue disorders     
Edema *  0/28 (0.00%)  0 1/30 (3.33%)  1
Folliculitis *  1/28 (3.57%)  1 0/30 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Unspecified, non-serious, adverse events
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Michael J. Kozal
Organization: Yale University School of Medicine: Internal Medicine: Infectious Diseases: AIDS Care Program / Viral Hepatitis Program
Phone: (203)737-4040
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00814879     History of Changes
Other Study ID Numbers: 0811004448
Yale-No Nukes
First Submitted: December 18, 2008
First Posted: December 25, 2008
Results First Submitted: November 23, 2015
Results First Posted: February 4, 2016
Last Update Posted: February 4, 2016