A Study to Evaluate the Safety and Efficacy of Adding Enfuvirtide to Oral Highly Active Antiretroviral Therapy (HAART) in Human Immunodeficiency Virus (HIV) Patients With Prior Treatment Experience (INTENSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00487188
First received: June 14, 2007
Last updated: May 14, 2012
Last verified: May 2012
Results First Received: March 22, 2011  
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: Enfuvirtide
Drug: Highly active antiretroviral treatment (HAART)

  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
A total of 47 patients were enrolled into the study at 20 investigational sites in France, Italy, Spain, Mexico, Germany and the US. Study starting 15NOV2005 and ending 5NOV2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In the Induction Phase participants were randomized (2:1 ratio) to receive ENF + HAART or HAART. In the Maintenance Phase participants in the HAART group who responded (viral load < 50 copies/mL) continued to receive HAART; those who responded in the ENF + HAART group were re-randomized (1:1 ratio) to receive ENF + HAART or HAART (ENF removed).

Reporting Groups
  Description
ENF + HAART Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
HAART Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
HAART (ENF Removed) Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.

Participant Flow for 2 periods

Period 1:   Induction Phase
    ENF + HAART     HAART     HAART (ENF Removed)  
STARTED     31     16     0 [1]
Safety Population     29     18 [2]   0  
COMPLETED     22     9     0  
NOT COMPLETED     9     7     0  
Abnormality of Laboratory Test                 0                 1                 0  
Adverse Event                 5                 0                 0  
Lack of Efficacy                 0                 1                 0  
Protocol Violation                 1                 0                 0  
Refused Treatment                 1                 2                 0  
Lost to Follow-up                 2                 2                 0  
Administrative                 0                 1                 0  
[1] Participants were only randomized to this treatment arm in the Maintenance Phase
[2] 2 patients randomized to ENF + HARRT only received treatment with HAART

Period 2:   Maintenance Phase
    ENF + HAART     HAART     HAART (ENF Removed)  
STARTED     10     8     9  
COMPLETED     7     8     8  
NOT COMPLETED     3     0     1  
Adverse Event                 1                 0                 0  
Death                 1                 0                 0  
Lost to Follow-up                 1                 0                 0  
Administrative                 0                 0                 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.
No text entered.

Reporting Groups
  Description
ENF+HAART Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
HAART Participants received highly active antiretroviral treatment.
Total Total of all reporting groups

Baseline Measures
    ENF+HAART     HAART     Total  
Number of Participants  
[units: participants]
  29     18     47  
Age  
[units: years]
Mean ± Standard Deviation
  44.1  ± 7.04     41.9  ± 10.57     43.3  ± 8.52  
Gender  
[units: participants]
     
Female     7     3     10  
Male     22     15     37  



  Outcome Measures
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1.  Primary:   Number of Participants With Viral Suppression: HIV-1 RNA < 50 Copies/mL During the Induction Phase   [ Time Frame: From Baseline 1 to Week 28 ]

2.  Secondary:   Time to Achieving HIV-1 RNA < 50 Copies/mL During the Induction Phase   [ Time Frame: Baseline 1 until Week 28. ]

3.  Secondary:   Number of Participants With Viral Suppression HIV-1 RNA < 400 Copies/mL During the Induction Phase   [ Time Frame: From Baseline 1 to Week 28 ]

4.  Secondary:   Change From Baseline to Week 24 in Viral Load   [ Time Frame: Baseline and Week 24 ]

5.  Secondary:   Change From Baseline to Week 24 in Cluster Differentiation Antigen Four Positive (CD4+) Cell Counts   [ Time Frame: Baseline and Week 24 ]

6.  Secondary:   Percentage of Induction Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks   [ Time Frame: Week 48 ]

7.  Secondary:   Percentage of Maintenance Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks   [ Time Frame: Week 48 ]

8.  Secondary:   Change From Baseline to Week 48 in Cluster Differentiation Antigen Four Positive (CD4) Cell Counts   [ Time Frame: Baseline 1 and Week 48 ]

9.  Secondary:   Time to Loss of Viral Response During the Maintenance Phase   [ Time Frame: From Baseline 2 to Week 48. ]

10.  Secondary:   Time to Virological Failure During the Maintenance Phase   [ Time Frame: From Baseline 2 to Week 48. ]

11.  Secondary:   Number of Participants With Virological Failure During the Maintenance Phase   [ Time Frame: From Baseline 2 to Week 48. ]

12.  Secondary:   Percentage of Participants Maintaining CD4+ Count During the Maintenance Phase   [ Time Frame: Baseline 2 to Week 48. ]

13.  Secondary:   Percentage of Participants With Improvement in CD4+ Count During the Maintenance Phase   [ Time Frame: Baseline 2 to Week 48. ]

14.  Secondary:   Number of Participants With Adverse Events (AEs) During the Induction Phase   [ Time Frame: Start of the study treatment until the end of the Induction Phase (Week 12 to Week 32) ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00487188     History of Changes
Other Study ID Numbers: MV18406
Study First Received: June 14, 2007
Results First Received: March 22, 2011
Last Updated: May 14, 2012
Health Authority: Spain: Agency of Medicines