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

This study has been completed.
Sponsor:
Collaborators:
Aaron Diamond AIDS Research Center
Merck Sharp & Dohme Corp.
Pfizer
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00525733
First received: September 5, 2007
Last updated: February 24, 2015
Last verified: January 2015
Results First Received: January 21, 2015  
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 800 mg
Drug: FTC 200 mg/TDF 300mg
Drug: Maraviroc
Drug: Raltegravir
Drug: Ritonavir 100 mg

  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
No text entered.

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
3-drug Standard Therapy

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)

5-drug Experimental Therapy

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)


Participant Flow:   Overall Study
    3-drug Standard Therapy     5-drug Experimental Therapy  
STARTED     14     26  
COMPLETED     11     23  
NOT COMPLETED     3     3  



  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.
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.

Reporting Groups
  Description
3-drug Standard Therapy

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)

5-drug Experimental Therapy

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 Total of all reporting groups

Baseline Measures
    3-drug Standard Therapy     5-drug Experimental Therapy     Total  
Number of Participants  
[units: participants]
  11     23     34  
Age  
[units: years]
Mean (Full Range)
  37    (25 to 48)     41    (29 to 69)     38    (25 to 69)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     11     23     34  
Region of Enrollment  
[units: participants]
     
United States     11     23     34  
Mean log baseline HIV-1 RNA  
[units: log┬ácopies/mL]
Mean (Full Range)
  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  
[units: cells/mm^3]
Mean (Full Range)
  539    (230 to 1066)     405    (305 to 524)     496    (230 to 1066)  



  Outcome Measures

1.  Primary:   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.   [ Time Frame: 48 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information
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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
e-mail: mmarkowitz@adarc.org


No publications provided


Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00525733     History of Changes
Other Study ID Numbers: MMA-0610-0607
Study First Received: September 5, 2007
Results First Received: January 21, 2015
Last Updated: February 24, 2015
Health Authority: United States: Food and Drug Administration