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Treatment of Acute HIV With Emtricitabine, Tenofovir and Efavirenz (CID 0805)

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ClinicalTrials.gov Identifier: NCT00924898
Recruitment Status : Completed
First Posted : June 19, 2009
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Collaborators:
Bristol-Myers Squibb
Gilead Sciences
Information provided by (Responsible Party):
Cynthia L Gay, MD, University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute HIV Infection
HIV Infections
Intervention Drug: efavirenz, emtricitabine, and tenofovir
Enrollment 92
Recruitment Details Individuals with acute HIV (AHI) detected via a statewide AHI screening program in publicly funded sites and primary care sites are reported to the NC Department of Health and Human Services (DHHS). DHHS staff immediately refer acute cases to HIV care. From Jan 2005 and Dec 2011, all AHI cases referred to UNC and Duke were offered enrollment.
Pre-assignment Details This was a single-arm, open-label study of emtricitabine/tenofovir/efavirenz started at enrollment. All participants received the same study treatment. Study treatment was not delayed for baseline resistance testing. Participants with transmitted baseline resistance to any drug in the regimen were followed on study on an alternative regimen.
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description This study was a dual-center, single-arm open-label study of the safety and efficacy of once daily, FTC/TDF/EFZ administered to participants with acute HIV infection
Period Title: Overall Study
Started 92
Completed 90
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description This study was a dual-center, single-arm open-label study of the safety and efficacy of once daily, FTC/TDF/EFZ administered to participants with acute HIV infection
Overall Number of Baseline Participants 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
<=18 years
0
   0.0%
Between 18 and 65 years
91
  98.9%
>=65 years
1
   1.1%
[1]
Measure Description: age (years) at time of acute HIV diagnosis
Age, Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 92 participants
27
(18 to 66)
[1]
Measure Description: Age at enrollment
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
Female
11
  12.0%
Male
81
  88.0%
[1]
Measure Description: Gender at birth was determined at screening.
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
Hispanic or Latino
2
   2.2%
Not Hispanic or Latino
90
  97.8%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 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
54
  58.7%
White
38
  41.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 92 participants
92
 100.0%
[1]
Measure Description: All participants were enrolled at either The University of North Carolina or Duke University.
CD4 cell count   [1] 
Median (Full Range)
Unit of measure:  Cells/mm^3
Number Analyzed 92 participants
487
(13 to 1316)
[1]
Measure Description: Baseline CD4 cell count
HIV RNA level   [1] 
Median (Full Range)
Unit of measure:  copies/mL
Number Analyzed 92 participants
614898
(615 to 29807640)
[1]
Measure Description: baseline HIV RNA level
Sexual risk group  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
Female
11
  12.0%
Heterosexual Male
9
   9.8%
Men who have sex with men
72
  78.3%
sexually transmitted diseases within 8 weeks prior to diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
14
  15.2%
[1]
Measure Description: Diagnosis of sexually transmitted disease within the 8 weeks prior to diagnosis with acute HIV
1.Primary Outcome
Title Number of Participants Without Virologic Failure at Week 24
Hide Description Number of participants with a HIV RNA level <200 copies/mL at week 24
Time Frame HIV RNA level prior to or at week 24 following enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
Participants suppressed to <200 copies/mL prior to or at week 24
Overall Number of Participants Analyzed 90
Measure Type: Count of Participants
Unit of Measure: Participants
81
  90.0%
2.Secondary Outcome
Title Number of Participants Without Virologic Failure at Week 48
Hide Description HIV RNA level <50 copies/mL at week 48
Time Frame HIV RNA level at week 48 following enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
Participants suppressed to <50 copies/mL prior at week 48
Overall Number of Participants Analyzed 90
Measure Type: Count of Participants
Unit of Measure: Participants
71
  78.9%
3.Secondary Outcome
Title Number of Participants With HIV RNA Suppression at Week 96
Hide Description Number of participants wtih HIV RNA level <50 copies/mL at week 96
Time Frame HIV RNA level at 96 weeks following enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
Participants who remained on study with viral suppression at week 96
Overall Number of Participants Analyzed 75
Measure Type: Count of Participants
Unit of Measure: Participants
65
  86.7%
4.Secondary Outcome
Title Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications
Hide Description Prevalence of any of the surveillance drug resistance mutations associated with resistance to antiretroviral medications listed by the World Health Organization
Time Frame At enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
Acute HIV infection treatment group
Overall Number of Participants Analyzed 92
Measure Type: Count of Participants
Unit of Measure: Participants
17
  18.5%
5.Secondary Outcome
Title Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment
Hide Description Baseline genotypic resistance defined as presence of any surveillance drug resistance mutation to any drug in the study treatment listed by the World Health Organization
Time Frame At enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
Baseline resistance testing was performed on all participants at enrollment.
Overall Number of Participants Analyzed 90
Measure Type: Count of Participants
Unit of Measure: Participants
71
  78.9%
6.Secondary Outcome
Title Time to HIV RNA Suppression <50 Copies/mL
Hide Description Number of days from ART initiation to HIV RNA suppression <50 copies/mL
Time Frame Number of days from start of study treatment until HIV RNA suppression, assessed through week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
Participants who remained on treatment at designated time points.
Overall Number of Participants Analyzed 89
Median (Full Range)
Unit of Measure: days
105
(14 to 523)
Time Frame Adverse events were collected for each participant over the 96 weeks of the study.
Adverse Event Reporting Description Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
 
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description Single-arml study of once daily emtricitabine/tenofovir/efavirenz administered to participants with acute HIV infection
All-Cause Mortality
Acute HIV Infection Treatment Group
Affected / at Risk (%)
Total   0/90 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Acute HIV Infection Treatment Group
Affected / at Risk (%) # Events
Total   0/90 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acute HIV Infection Treatment Group
Affected / at Risk (%) # Events
Total   52/90 (57.78%)    
Eye disorders   
Eye Swelling  2  1/90 (1.11%)  1
Vision Blurred  2  1/90 (1.11%)  1
Visual Impairment  2  1/90 (1.11%)  1
Gastrointestinal disorders   
Abdominal Discomfort  1  2/90 (2.22%)  2
Abdominal Distension  1  1/90 (1.11%)  1
Abdominal Pain  2  3/90 (3.33%)  3
Abdominal Pain Upper  2  1/90 (1.11%)  1
Diarrhoea  2  7/90 (7.78%)  8
Dry Mouth  2  1/90 (1.11%)  1
Dyspepsia  2  1/90 (1.11%)  1
Flatulence  2  1/90 (1.11%)  1
Lip Swelling  2  1/90 (1.11%)  1
Nausea  2  16/90 (17.78%)  16
Vomiting  2  6/90 (6.67%)  7
General disorders   
fatigue  2  4/90 (4.44%)  4
Feeling Abnormal  2  3/90 (3.33%)  3
Feeling Drunk  2  2/90 (2.22%)  2
Feeling Jittery  2  4/90 (4.44%)  4
Hangover  2  1/90 (1.11%)  1
Sluggishness  2  1/90 (1.11%)  1
Unevaluable Event  2  3/90 (3.33%)  3
Infections and infestations   
Lipase Increased  2  2/90 (2.22%)  2
Injury, poisoning and procedural complications   
Post Lumbar Puncture Syndrome  2  1/90 (1.11%)  1
Investigations   
Alanine Aminotransferase Increased  2  4/90 (4.44%)  4
Aspartate Aminotransferase Increased  2  3/90 (3.33%)  3
Blood Cholesterol Increased  2  3/90 (3.33%)  4
Blood Triglycerides Increased  2  1/90 (1.11%)  1
Low Density Lipoprotein Increased  2  2/90 (2.22%)  2
Neutrophil Count Decreased  2  1/90 (1.11%)  1
Metabolism and nutrition disorders   
Decreased Appetite  2  2/90 (2.22%)  2
Hypertriglyceridaemia  2  1/90 (1.11%)  1
Musculoskeletal and connective tissue disorders   
Back Pain  2  1/90 (1.11%)  1
Nervous system disorders   
Balance Disorder  2  8/90 (8.89%)  8
Disturbance in Attention  2  4/90 (4.44%)  4
Dizziness  2  25/90 (27.78%)  30
Headache  2  12/90 (13.33%)  15
Memory Impairment  1  1/90 (1.11%)  1
Poor Quality Sleep  2  1/90 (1.11%)  1
Somnolence  2  9/90 (10.00%)  9
Syncope  2  1/90 (1.11%)  1
Tunnel Vision  2  1/90 (1.11%)  1
Visual Field Defect  2  1/90 (1.11%)  1
Psychiatric disorders   
Abnormal Dreams  2  9/90 (10.00%)  11
Anger  2  1/90 (1.11%)  1
Anxiety  2  5/90 (5.56%)  5
Claustrophobia  2  1/90 (1.11%)  1
Depressed Mood  2  2/90 (2.22%)  3
Depression  2  3/90 (3.33%)  3
Euphoric Mood  2  1/90 (1.11%)  1
Initial Insomnia  2  2/90 (2.22%)  2
Insomnia  2  12/90 (13.33%)  12
Irritability  2  3/90 (3.33%)  3
Mood Swings  2  2/90 (2.22%)  2
Obsessive Thoughts  2  1/90 (1.11%)  1
Sleep Disorder  2  1/90 (1.11%)  1
Skin and subcutaneous tissue disorders   
Erythema  2  1/90 (1.11%)  1
Night Sweats  2  1/90 (1.11%)  1
Pruritis  2  4/90 (4.44%)  4
Pruritis Generalised  2  2/90 (2.22%)  2
Rash  2  6/90 (6.67%)  11
Rash Maculo-papular  2  2/90 (2.22%)  6
Rash Papular  2  3/90 (3.33%)  3
Rash Pruritic  2  1/90 (1.11%)  3
Swelling Face  2  1/90 (1.11%)  1
Vascular disorders   
Flushing  2  1/90 (1.11%)  1
1
Term from vocabulary, MedDRA (10.0)
2
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Cynthia Gay
Organization: The University of North Carolina
Phone: 919-843-2726
Publications of Results:
C Gay, A Johnson, S McCoy, J Kuruc, K McGee, L McNeil, M Kerkau, J Sebastian, C Pilcher, D Margolis, P Leone, S Fiscus, G Ferrari, C Hicks, J Eron, The Duke-UNC Acute HIV Infection Consortium. "Efficacy of NNRTI-based antiretroviral therapy initiated during acute HIV infection." XVII International AIDS Conference, 2008 Abstract no. THPE0082.
Responsible Party: Cynthia L Gay, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00924898     History of Changes
Other Study ID Numbers: CID 0805 (PHI 02)
First Submitted: June 17, 2009
First Posted: June 19, 2009
Results First Submitted: February 8, 2017
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017