Treatment of Acute HIV Infection With Quad Fixed-dose Combination (FDC) Tablet (PHI04)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01694420
Recruitment Status : Completed
First Posted : September 27, 2012
Results First Posted : December 23, 2016
Last Update Posted : April 12, 2017
Information provided by (Responsible Party):
Duke University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV
Intervention: Drug: (FDC) ELV/COBI/FTC/TDF

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants for this study are recruited from AHI participants referred to our ID clinics. Referrals are generated from the NC STAT Program and from clinical diagnoses made by both internal and external health care clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Quad FDC

FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks

(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment

Participant Flow:   Overall Study
    Quad FDC
Lost to Follow-up                3 

  Baseline Characteristics

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
Quad FDC

FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks

(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment

Baseline Measures
   Quad FDC 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      33 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      6  18.2% 
Male      27  81.8% 

  Outcome Measures

1.  Primary:   Number of Participants With a Viral Load Measurement of <200 Copies/mL at Week 24   [ Time Frame: 24 weeks ]

2.  Primary:   Virologic Efficacy of the Fixed Dose Combination (FDC) ELV/COBI/FTC/TDF Given Once Daily to Participants With Acute HIV Infection as Determined by the Proportion of Treated Participants With HIV-1 RNA to <50 Copies/mL at Week 48   [ Time Frame: 48 weeks ]

3.  Secondary:   Immune Activation as Measured by the Proportion of CD4+ and CD8+ Cells Expressing HLA-DR and CD38+   [ Time Frame: 48 weeks ]

4.  Secondary:   Rate of Virologic Decline in the First 48 Weeks of Treatment Comparing FDC ELV/COBI/FTC/TDF to FDC EFV/FTC/TDF   [ Time Frame: 48 weeks ]

5.  Other Pre-specified:   Number of Participants With Grade 3 or Grade 4 Adverse Events   [ Time Frame: 48 weeks ]

6.  Other Pre-specified:   Number of Participants With Adverse Events Related to Study Drug   [ Time Frame: 48 weeks ]

  Serious Adverse Events

  Other Adverse Events

  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
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  More Information

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: Mehri McKeller, MD
Organization: Duke University Medical Center
phone: 919-668-0242


Responsible Party: Duke University Identifier: NCT01694420     History of Changes
Other Study ID Numbers: Pro00035447
IN-US-236-0124 ( Other Grant/Funding Number: Funder )
First Submitted: September 21, 2012
First Posted: September 27, 2012
Results First Submitted: October 31, 2016
Results First Posted: December 23, 2016
Last Update Posted: April 12, 2017