Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sonya Heath, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00734344
First received: August 12, 2008
Last updated: April 25, 2016
Last verified: April 2016
Results First Received: January 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acute HIV Infection
Interventions: Drug: Raltegravir
Drug: Efavirenz
Drug: Emtricitibine
Drug: Tenofovir disoproxil once daily
Drug: Tenofovir disoproxil twice daily

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm 1

Raltegravir plus Truvada

Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily

Arm 2

Efavirenz plus Truvada

Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily


Participant Flow:   Overall Study
    Arm 1     Arm 2  
STARTED     9     9  
COMPLETED     9     9  
NOT COMPLETED     0     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.
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Reporting Groups
  Description
Arm 1

Raltegravir plus Truvada

Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily

Arm 2

Efavirenz plus Truvada

Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily

Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  9     9     18  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     9     18  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     0     2     2  
Male     9     7     16  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     4     4     8  
White     5     5     10  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     9     9     18  



  Outcome Measures
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1.  Primary:   Mean White Blood Cell Count Between Treatment Groups at 2 Months   [ Time Frame: baseline to 2 months ]

2.  Primary:   Mean White Blood Cell Count Between Treatment Groups at 4 Months   [ Time Frame: 4 months post baseline ]

3.  Primary:   Mean White Blood Cell Count Between Treatment Groups at 6 Months   [ Time Frame: 6 months after baseline ]

4.  Primary:   Mean White Blood Cell Count Between Treatment Groups at 8 Months   [ Time Frame: 8 months after baseline ]

5.  Primary:   Mean White Blood Cell Count Between Treatment Groups at 10 Months   [ Time Frame: 10 months after baseline ]

6.  Primary:   Mean White Blood Cell Count Between Treatment Groups at 12 Months   [ Time Frame: 12 months after baseline ]

7.  Primary:   Mean White Blood Cell Count Between Treatment Groups at 14 Months   [ Time Frame: 14 months after baseline ]

8.  Primary:   Mean Hematocrit Between Treatment Groups at 2 Months   [ Time Frame: 2 months after baseline ]

9.  Primary:   Mean Hematocrit Between Treatment Groups at 4 Months   [ Time Frame: 4 months after baseline ]

10.  Primary:   Mean Hematocrit Between Treatment Groups at 6 Months   [ Time Frame: 6 months after baseline ]

11.  Primary:   Mean Hematocrit Between Treatment Groups at 8 Months   [ Time Frame: 8 months after baseline ]

12.  Primary:   Mean Hematocrit Between Treatment Groups at 10 Months   [ Time Frame: 10 months after baseline ]

13.  Primary:   Mean Hematocrit Between Treatment Groups at 12 Months   [ Time Frame: 12 months after baseline ]

14.  Primary:   Mean Hematocrit Between Treatment Groups at 14 Months   [ Time Frame: 14 months after baseline ]

15.  Primary:   Mean Platelet Count Between Treatment Groups at 2 Months   [ Time Frame: 2 months after baseline ]

16.  Primary:   Mean Platelet Count Between Treatment Groups at 4 Months   [ Time Frame: 4 months after baseline ]

17.  Primary:   Mean Platelet Count Between Treatment Groups at 6 Months   [ Time Frame: 6 months after baseline ]

18.  Primary:   Mean Platelet Count Between Treatment Groups at 8 Months   [ Time Frame: 8 months after baseline ]

19.  Primary:   Mean Platelet Count Between Treatment Groups at 10 Months   [ Time Frame: 10 months after baseline ]

20.  Primary:   Mean Platelet Count Between Treatment Groups at 12 Months   [ Time Frame: 12 months after baseline ]

21.  Primary:   Mean Platelet Count Between Treatment Groups at 14 Months   [ Time Frame: 4 months after baseline ]

22.  Primary:   Mean CD4 Count Between Treatment Groups at 1 Months   [ Time Frame: 1 month after baseline ]

23.  Primary:   Mean CD4 Count Between Treatment Groups at 2 Months   [ Time Frame: 2 months after baseline ]

24.  Primary:   Mean CD4 Count Between Treatment Groups at 3 Months   [ Time Frame: 3 months after baseline ]

25.  Primary:   Mean CD4 Count Between Treatment Groups at 4 Months   [ Time Frame: 4 months after baseline ]

26.  Primary:   Mean CD4 Count Between Treatment Groups at 5 Months   [ Time Frame: 5 months after baseline ]

27.  Primary:   Mean CD4 Count Between Treatment Groups at 6 Months   [ Time Frame: 6 months after baseline ]

28.  Primary:   Mean CD4 Count Between Treatment Groups at 7 Months   [ Time Frame: 7 months after baseline ]

29.  Primary:   Mean CD4 Count Between Treatment Groups at 8 Months   [ Time Frame: 8 months after baseline ]

30.  Primary:   Mean CD4 Count Between Treatment Groups at 9 Months   [ Time Frame: 9 months after baseline ]

31.  Primary:   Mean CD4 Count Between Treatment Groups at 10 Months   [ Time Frame: 10 months after baseline ]

32.  Primary:   Mean CD4 Count Between Treatment Groups at 11 Months   [ Time Frame: 11 months after baseline ]


  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: Principal Investigator
Organization: University of Alabama at Bimingham
phone: 996-2371
e-mail: heaths@uab.edu



Responsible Party: Sonya Heath, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00734344     History of Changes
Other Study ID Numbers: F080416007
Study First Received: August 12, 2008
Results First Received: January 5, 2016
Last Updated: April 25, 2016
Health Authority: United States: Institutional Review Board