Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients (RAN)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00762892
First received: September 26, 2008
Last updated: December 19, 2014
Last verified: December 2014
Results First Received: December 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Raltegravir and truvada
Drug: Atazanavir, Norvir and Truvada

  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
approached patients HIV positive, naive to therapy, single site, English and Spanish speaking/writing.

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
Raltegravir

Raltegravir in combination with truvada (tenofovir and emtricitabine)

Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily

Atazanavir

Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)

Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily


Participant Flow:   Overall Study
    Raltegravir     Atazanavir  
STARTED     14     14  
COMPLETED     9     8  
NOT COMPLETED     5     6  
Lost to Follow-up                 2                 5  
Withdrawal by Subject                 0                 1  
Death                 1                 0  
Pregnancy                 1                 0  
Incarceration                 1                 0  



  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
Raltegravir

Raltegravir in combination with truvada (tenofovir and emtricitabine)

Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily

Atazanavir

Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)

Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily

Total Total of all reporting groups

Baseline Measures
    Raltegravir     Atazanavir     Total  
Number of Participants  
[units: participants]
  14     14     28  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     14     28  
>=65 years     0     0     0  
Age  
[units: year]
Mean (Standard Deviation)
  40.7  (11)     38.8  (10)     39.8  (10.4)  
Gender  
[units: participants]
     
Female     7     3     10  
Male     7     11     18  
Region of Enrollment  
[units: participants]
     
United States     14     14     28  



  Outcome Measures
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1.  Primary:   Change From Baseline in CD4 Count at 48 Weeks   [ Time Frame: Baseline and 48 weeks ]

2.  Primary:   Change From Baseline in Log HIV Viral Load at 48 Weeks   [ Time Frame: Baseline and 48 weeks ]

3.  Secondary:   Change From Baseline in Lipids at 48 Weeks   [ Time Frame: Baseline and 48 weeks ]

4.  Secondary:   Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks   [ Time Frame: Baseline and 48 weeks ]

5.  Secondary:   Change From Baseline in Homocysteine at 6 Months   [ Time Frame: Baseline and 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
Limitations are the relatively small sample size and loss to follow-up. Medical records of patients that were lost to follow up was reviewed to ensure that no SAE occurred. We also attempted multiple times to contact patients.


  More Information
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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: Tanvir Bell, MD
Organization: UT Health Science Center Houston
phone: 713-500-6759
e-mail: Tanvir.K.Bell@uth.tmc.edu


No publications provided


Responsible Party: Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00762892     History of Changes
Other Study ID Numbers: raltegravir atazanavir naive
Study First Received: September 26, 2008
Results First Received: December 19, 2014
Last Updated: December 19, 2014
Health Authority: United States: Institutional Review Board