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Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects (HIV)

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ClinicalTrials.gov Identifier: NCT00654147
Recruitment Status : Completed
First Posted : April 7, 2008
Results First Posted : July 13, 2015
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
Margaret A. Fischl, M.D., University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Raltegravir & Lopinavir/ritonavir
Drug: Raltegravir and emtricitabine/tenofovir
Enrollment 44
Recruitment Details Patients were randomly assigned to receive one of two regimens Raltegravir (Isentress, Merck & Company) 400 mg twice daily with either Lopinavir/ritonavir (Kaletra, Abbott Laboratories) 200 mg/100 mg twice daily or with emtricitabine/tenofovir (Truvada, Gilead Sciences) 200 mg/100 mg twice daily.
Pre-assignment Details Participants with acute or recent HIV-1 infection, major resistance-associated mutation on any genotype performed at any time prior to study entry, serious illness requiring systemic treatment and/or hospitalization within 7 days of study entry, HBsAg positivity, acute hepatitis of any etiology, clinically significant liver disease were excluded
Arm/Group Title Raltegravir & Lopinavir/Ritonavir Raltegravir & Emtricitabine/Tenofovir
Hide Arm/Group Description

Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks

Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks

Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks

Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48

Period Title: Overall Study
Started 21 23
Completed 19 19
Not Completed 2 4
Arm/Group Title Raltegravir & Lopinavir/Ritonavir Raltegravir & Emtricitabine/Tenofovir Total
Hide Arm/Group Description

Raltegravir 400 mg tablet every 12 hours for 48 & Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks

Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks

Raltegravir 400 mg tablet every 12 hours for 48 weeks & emtricitabine 200mg/ tenofovir 300 mg tab once daily for 48 weeks

Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48

Total of all reporting groups
Overall Number of Baseline Participants 21 23 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 23 participants 44 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
 100.0%
23
 100.0%
44
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 23 participants 44 participants
Female
3
  14.3%
1
   4.3%
4
   9.1%
Male
18
  85.7%
22
  95.7%
40
  90.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 23 participants 44 participants
Hispanic or Latino
13
  61.9%
15
  65.2%
28
  63.6%
Not Hispanic or Latino
8
  38.1%
8
  34.8%
16
  36.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 23 participants 44 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
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
9
  42.9%
7
  30.4%
16
  36.4%
White
12
  57.1%
16
  69.6%
28
  63.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 23 participants 44 participants
21 23 44
1.Primary Outcome
Title Time to Confirmed Virologic Failure
Hide Description time to confirmed viologic failure at 24 weeks (up to 48 weeks)
Time Frame weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
descriptive
Arm/Group Title Raltegravir & Lopinavir/Ritonavir Raltegravir & Emtricitabine/Tenofovir
Hide Arm/Group Description:

Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks

Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks

Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks

Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48

Overall Number of Participants Analyzed 21 23
Median (95% Confidence Interval)
Unit of Measure: weeks
28
(25 to 56)
29
(21 to 56)
2.Primary Outcome
Title Time to Virologic Failure
Hide Description time to virologic failure at week 24 (up to 48 weeks)
Time Frame week 24 (up to 48 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir & Lopinavir/Ritonavir Raltegravir & Emtricitabine/Tenofovir
Hide Arm/Group Description:

Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks

Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks

Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks

Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48

Overall Number of Participants Analyzed 21 23
Median (Standard Deviation)
Unit of Measure: weeks
3.2296  (0.1596) 2.9952  (0.1812)
3.Secondary Outcome
Title Study Medication Toxicity-related Discontinuation .
Hide Description grade 3 and grade 4 symptoms and laboratory study treatment limiting toxicity
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir & Lopinavir/Ritonavir Raltegravir & Emtricitabine/Tenofovir
Hide Arm/Group Description:

Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks

Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks

Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks

Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48

Overall Number of Participants Analyzed 21 23
Measure Type: Number
Unit of Measure: participants
1 0
4.Secondary Outcome
Title Weeks to HIV-1 RNA <200 Copies/ml
Hide Description time to viral suppression noted as week on study treatment to attain HIV-1 RNA < 200 copies/ml
Time Frame from date of treatment start to first week documented viral suppression
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir & Lopinavir/Ritonavir Raltegravir & Emtricitabine/Tenofovir
Hide Arm/Group Description:

Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks

Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks

Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks

Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48

Overall Number of Participants Analyzed 21 23
Median (95% Confidence Interval)
Unit of Measure: week to viral supresssion
week to <200 Copies/ml
28
(14 to 56)
28
(14 to 33)
week to <50 Copies/ml
56
(28 to 108)
56
(28 to 57)
5.Secondary Outcome
Title Change From Baseline CD4+ and CD8+ Cell Counts
Hide Description mean change in CD4+ and CD8+ T-lymphocytes counts from baseline (defined as the average of pre-entry and entry values) at weeks 16 and 24 in the two treatment arms
Time Frame Baseline, Weeks 16 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Change from baseline compared between arms using repeated measures analysis of covariance. Linear mixed models used to accomplish these analyses.
Arm/Group Title Raltegravir & Lopinavir/Ritonavir Raltegravir & Emtricitabine/Tenofovir
Hide Arm/Group Description:

Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks

Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks

Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks

Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48

Overall Number of Participants Analyzed 21 23
Mean (Standard Error)
Unit of Measure: cells/mm3
week 16 CD4 cells 516.34  (76.52) 452.11  (92.48)
week 24 CD4 cells 521.31  (76.52) 482.36  (93.32)
6.Secondary Outcome
Title Study Medication Tolerability
Hide Description study treatment tolerability as measured by number of subjects receiving study treatment who either discontinued or changed any component of study treatment
Time Frame date started study treatment to first week documented change study treatment up to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir & Lopinavir/Ritonavir Raltegravir & Emtricitabine/Tenofovir
Hide Arm/Group Description:

Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks

Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks

Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks

Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48

Overall Number of Participants Analyzed 21 23
Measure Type: Number
Unit of Measure: participants
1 0
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Raltegravir & Lopinavir/Ritonavir Raltegravir & Emtricitabine/Tenofovir
Hide Arm/Group Description

Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks

Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks

Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks

Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48

All-Cause Mortality
Raltegravir & Lopinavir/Ritonavir Raltegravir & Emtricitabine/Tenofovir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Raltegravir & Lopinavir/Ritonavir Raltegravir & Emtricitabine/Tenofovir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/21 (19.05%)      0/23 (0.00%)    
Endocrine disorders     
trigylcerides  1 [1]  2/21 (9.52%)  3 0/23 (0.00%)  0
Hepatobiliary disorders     
Total bilirubin  1 [2]  2/21 (9.52%)  2 0/23 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, Serious
[1]
grade 3 or greater elevation in fasting blood triglycerides
[2]
grade 3 or greater elevation in total bilirubin
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Raltegravir & Lopinavir/Ritonavir Raltegravir & Emtricitabine/Tenofovir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/21 (4.76%)      0/23 (0.00%)    
Gastrointestinal disorders     
nausea and vomiting  1  1/21 (4.76%)  1 0/23 (0.00%)  0
diarrhea  1  1/21 (4.76%)  1 0/23 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, Serious
Pilot study with 44 subjects and generalization f results is limited by the small sample size.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director AIDS Clinical Research Unit
Organization: University of Miami School of Medicine
Phone: 305-243-3838
Responsible Party: Margaret A. Fischl, M.D., University of Miami
ClinicalTrials.gov Identifier: NCT00654147     History of Changes
Other Study ID Numbers: A009
First Submitted: April 2, 2008
First Posted: April 7, 2008
Results First Submitted: January 20, 2015
Results First Posted: July 13, 2015
Last Update Posted: August 3, 2015