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Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01)

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ClinicalTrials.gov Identifier: NCT00525733
Recruitment Status : Completed
First Posted : September 6, 2007
Results First Posted : March 9, 2015
Last Update Posted : March 9, 2015
Sponsor:
Collaborators:
Aaron Diamond AIDS Research Center
Merck Sharp & Dohme Corp.
Pfizer
Information provided by (Responsible Party):
Rockefeller University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: darunavir 800 mg
Drug: FTC 200 mg/TDF 300mg
Drug: Maraviroc
Drug: Raltegravir
Drug: Ritonavir 100 mg
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 3-drug Standard Therapy 5-drug Experimental Therapy
Hide Arm/Group Description

FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD

darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)

Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)

FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID

darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)

Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)

Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)

Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)

Period Title: Overall Study
Started 14 26
Completed 11 23
Not Completed 3 3
Arm/Group Title 3-drug Standard Therapy 5-drug Experimental Therapy Total
Hide Arm/Group Description

FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD

darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)

Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)

FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID

darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)

Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)

Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)

Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)

Total of all reporting groups
Overall Number of Baseline Participants 11 23 34
Hide Baseline Analysis Population Description
This is an as treated analysis. Baseline characteristics describe subjects available for primary endpoint analysis at week 48. There were 34 subjects available for primary endpoint analysis however 2 subjects were not able to be analyzed due to primer mismatch therefore results are available for 32 subjects in the primary endpoint analysis.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants 23 participants 34 participants
37
(25 to 48)
41
(29 to 69)
38
(25 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 23 participants 34 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
11
 100.0%
23
 100.0%
34
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 23 participants 34 participants
11 23 34
Mean log baseline HIV-1 RNA  
Mean (Full Range)
Unit of measure:  Log copies/mL
Number Analyzed 11 participants 23 participants 34 participants
5.6
(3.1 to 6.4)
6.3
(4.8 to 7.0)
5.8
(3.1 to 7.0)
Mean CD4+ T-cell count  
Mean (Full Range)
Unit of measure:  Cells/mm^3
Number Analyzed 11 participants 23 participants 34 participants
539
(230 to 1066)
405
(305 to 524)
496
(230 to 1066)
1.Primary Outcome
Title The Primary Outcome of This Study is the Proportion of Patients Having Detectable HIV-1 RNA Using the Single Copy Assay After 48 Weeks of Treatment and the Study Hypothesis is That New Treatment is Better Than the Control Group.
Hide Description [Not Specified]
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3-drug Standard Therapy 5-drug Experimental Therapy
Hide Arm/Group Description:

FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD

darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)

Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)

FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID

darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)

Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)

Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)

Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)

Overall Number of Participants Analyzed 11 21
Measure Type: Number
Unit of Measure: # subjects without detectable viremia
3 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3-drug Standard Therapy, 5-drug Experimental Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 3-drug Standard Therapy 5-drug Experimental Therapy
Hide Arm/Group Description

FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD

darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)

Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)

FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID

darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)

Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)

Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)

Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)

All-Cause Mortality
3-drug Standard Therapy 5-drug Experimental Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
3-drug Standard Therapy 5-drug Experimental Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
3-drug Standard Therapy 5-drug Experimental Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/23 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Martin Markowitz MD
Organization: Aaron Diamond AIDS Research Center
Phone: 212-448-5020
Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00525733     History of Changes
Other Study ID Numbers: MMA-0610-0607
First Submitted: September 5, 2007
First Posted: September 6, 2007
Results First Submitted: January 21, 2015
Results First Posted: March 9, 2015
Last Update Posted: March 9, 2015