Elvucitabine/Efavirenz/Tenofovir vs. Lamivudine/Efavirenz/Tenofovir in HIV-1 Infected, Treatment Naive Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Achillion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00350272
First received: July 6, 2006
Last updated: May 16, 2016
Last verified: May 2016
Results First Received: February 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: elvucitabine
Drug: Lamivudine
Drug: Tenofovir
Drug: Efavirenz

  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
HIV-1–infected, treatment-naïve adults with no AIDS-defining events in the 3 months prior to Screening and with plasma HIV-1 RNA levels greater than or equal to 5000 copies/mL and CD4 counts greater than or equal to 200 cells/μL and less than 500 cells/μL and HIV-1 strains absent the M184V, M184I, D237E, K103, Y188L, and K65R mutations at Screen.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 78 were given a treatment assignment. One subject assigned to treatment was ineligible for randomization and did not receive any study drug. An additional subject did not take any of the dispensed study drug. Therefore 76 subjects were treated.

Reporting Groups
  Description
Elvucitabine, Efavirenz,Tenofovir Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
Lamivudine,Efavirenz,Tenofovir Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).

Participant Flow for 2 periods

Period 1:   Blinded 12 Week Treatment
    Elvucitabine, Efavirenz,Tenofovir     Lamivudine,Efavirenz,Tenofovir  
STARTED     39     37  
COMPLETED     30     35  
NOT COMPLETED     9     2  
Adverse Event                 1                 0  
Death                 1                 0  
Lost to Follow-up                 2                 0  
Withdrawal by Subject                 3                 0  
Physician Decision                 2                 1  
Sponsor decision                 0                 1  

Period 2:   Open-Label 84 Week Treatment
    Elvucitabine, Efavirenz,Tenofovir     Lamivudine,Efavirenz,Tenofovir  
STARTED     30     35  
COMPLETED     21     27  
NOT COMPLETED     9     8  
Adverse Event                 2                 1  
Lost to Follow-up                 3                 2  
Withdrawal by Subject                 1                 2  
Physician Decision                 1                 2  
Sponsor decision                 2                 1  



  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.
The baseline analysis population was the safety population, defined as all randomized subjects who received at least one dose of study drug.

Reporting Groups
  Description
Lamivudine Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
Elvucitabine Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
Total Total of all reporting groups

Baseline Measures
    Lamivudine     Elvucitabine     Total  
Number of Participants  
[units: participants]
  37     39     76  
Age  
[units: years]
Mean (Standard Deviation)
  36.4  (11.34)     37.1  (10.20)     36.6  (10.71)  
Gender  
[units: participants]
     
Female     8     7     15  
Male     29     32     61  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     8     13     21  
Not Hispanic or Latino     29     26     55  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     10     9     19  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     6     7     13  
White     21     22     43  
More than one race     0     0     0  
Unknown or Not Reported     0     1     1  
Height  
[units: inches]
Mean (Standard Deviation)
  67.33  (4.325)     68.18  (4.433)     67.77  (4.373)  
Weight  
[units: pounds]
Mean (Standard Deviation)
  171.37  (52.582)     162.03  (41.272)     166.58  (47.035)  



  Outcome Measures
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1.  Primary:   The Proportion of Subjects With Virologic Response for 10 mg/Day Elvucitabine in HIV-1-infected Subjects by 12 Weeks Compared With the Proportion of Subjects With Lamivudine 300 mg/Day.   [ Time Frame: 12 Weeks ]

2.  Primary:   The Safety Profile of Elvucitabine.   [ Time Frame: 12 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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Kevin Kucharski, VP of Clinical Operations
Organization: Achillion Pharmaceuticals, Inc.
phone: 203-624-7000
e-mail: Kkucharski@achillion.com



Responsible Party: Achillion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00350272     History of Changes
Other Study ID Numbers: ACH443-015
Study First Received: July 6, 2006
Results First Received: February 22, 2016
Last Updated: May 16, 2016
Health Authority: United States: Food and Drug Administration