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

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ClinicalTrials.gov Identifier: NCT01694420
Recruitment Status : Completed
First Posted : September 27, 2012
Results First Posted : December 23, 2016
Last Update Posted : April 12, 2017
Sponsor:
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
Enrollment 33

Recruitment Details 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  
Arm/Group Title Quad FDC
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FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks

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

Period Title: Overall Study
Started 33
Completed 30
Not Completed 3
Reason Not Completed
Lost to Follow-up             3
Arm/Group Title Quad FDC
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FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks

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

Overall Number of Baseline Participants 33
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[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
<=18 years
0
   0.0%
Between 18 and 65 years
33
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
6
  18.2%
Male
27
  81.8%
1.Primary Outcome
Title Number of Participants With a Viral Load Measurement of <200 Copies/mL at Week 24
Hide Description [Not Specified]
Time Frame 24 weeks
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[Not Specified]
Arm/Group Title Quad FDC
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FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks

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

Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
28
2.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quad FDC
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FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks

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

Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
24
3.Secondary Outcome
Title Immune Activation as Measured by the Proportion of CD4+ and CD8+ Cells Expressing HLA-DR and CD38+
Hide Description [Not Specified]
Time Frame 48 weeks
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Data not collected
Arm/Group Title Quad FDC
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FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Rate of Virologic Decline in the First 48 Weeks of Treatment Comparing FDC ELV/COBI/FTC/TDF to FDC EFV/FTC/TDF
Hide Description [Not Specified]
Time Frame 48 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quad FDC
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FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks

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

Overall Number of Participants Analyzed 30
Median (Full Range)
Unit of Measure: days
HIV RNA <200 copies/mL
26
(7 to 132)
HIV RNA <50 copies/mL
54
(12 to 251)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Quad FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Study data compared to data as cited in PubMed ID: 21487250
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Other Pre-specified Outcome
Title Number of Participants With Grade 3 or Grade 4 Adverse Events
Hide Description [Not Specified]
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
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[Not Specified]
Arm/Group Title Quad FDC
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FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks

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

Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
Grade 3 3
Grade 4 0
6.Other Pre-specified Outcome
Title Number of Participants With Adverse Events Related to Study Drug
Hide Description [Not Specified]
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quad FDC
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FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks

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

Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
22
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quad FDC
Hide Arm/Group Description

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

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

All-Cause Mortality
Quad FDC
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quad FDC
Affected / at Risk (%)
Total   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Quad FDC
Affected / at Risk (%)
Total   22/33 (66.67%) 
Blood and lymphatic system disorders   
Anemia  1/33 (3.03%) 
Decreased neutrophils  2/33 (6.06%) 
Endocrine disorders   
Elevated cholesterol  1/33 (3.03%) 
Hypothyroidism  1/33 (3.03%) 
Gastrointestinal disorders   
Constipation  1/33 (3.03%) 
Diarrhea  6/33 (18.18%) 
Flatulence  2/33 (6.06%) 
Increased appetite  1/33 (3.03%) 
Nausea  6/33 (18.18%) 
Shigella colitis  2/33 (6.06%) 
stomach cramping  1/33 (3.03%) 
Vomiting  2/33 (6.06%) 
General disorders   
Decreased appetite  1/33 (3.03%) 
Dry mouth  1/33 (3.03%) 
Fatigue  5/33 (15.15%) 
Feeling of air stuck in throat  1/33 (3.03%) 
Hot flashes  1/33 (3.03%) 
Alteration in taste  1/33 (3.03%) 
Night sweats  1/33 (3.03%) 
thigh weakness  1/33 (3.03%) 
Weight loss  1/33 (3.03%) 
Hepatobiliary disorders   
Elevated ALT  4/33 (12.12%) 
Elevated AST  5/33 (15.15%) 
Elevated lipase  1/33 (3.03%) 
Injury, poisoning and procedural complications   
Chest wall injury  1/33 (3.03%) 
Metabolism and nutrition disorders   
Hypertriglyceridemia  2/33 (6.06%) 
Nervous system disorders   
Decreased comprehension  1/33 (3.03%) 
Dizziness  1/33 (3.03%) 
Headache  7/33 (21.21%) 
Short term memory loss  1/33 (3.03%) 
Psychiatric disorders   
Anxiety  1/33 (3.03%) 
Renal and urinary disorders   
Elevated creatinine  1/33 (3.03%) 
Proteinuria  2/33 (6.06%) 
Skin and subcutaneous tissue disorders   
Disseminated itching  1/33 (3.03%) 
Rash  2/33 (6.06%) 
thinning hair  1/33 (3.03%) 
Surgical and medical procedures   
Elevated BP during leukapheresis  7/33 (21.21%) 
Tingling around lips during leukaphersis  4/33 (12.12%) 
1
Term from vocabulary, CTCAE version 4
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
Publications:
Responsible Party: Duke University
ClinicalTrials.gov 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