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

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Gilead Sciences
Information provided by (Responsible Party):
Cynthia L Gay, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00924898
First received: June 17, 2009
Last updated: April 6, 2017
Last verified: April 2017
Results First Received: February 8, 2017  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Acute HIV Infection Treatment Group 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

Participant Flow:   Overall Study
    Acute HIV Infection Treatment Group
STARTED   92 
COMPLETED   90 
NOT COMPLETED   2 
Withdrawal by Subject                2 



  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
Acute HIV Infection Treatment Group 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

Baseline Measures
   Acute HIV Infection Treatment Group 
Overall Participants Analyzed 
[Units: Participants]
 92 
Age [1] 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      91  98.9% 
>=65 years      1   1.1% 
[1] age (years) at time of acute HIV diagnosis
Age [1] 
[Units: Years]
Median (Full Range)
 27 
 (18 to 66) 
[1] Age at enrollment
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
 
Female      11  12.0% 
Male      81  88.0% 
[1] Gender at birth was determined at screening.
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2   2.2% 
Not Hispanic or Latino      90  97.8% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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] 
[Units: Participants]
Count of Participants
 
United States   92 
[1] All participants were enrolled at either The University of North Carolina or Duke University.
CD4 cell count [1] 
[Units: Cells/mm^3]
Median (Full Range)
 487 
 (13 to 1316) 
[1] Baseline CD4 cell count
HIV RNA level [1] 
[Units: copies/mL]
Median (Full Range)
 614898 
 (615 to 29807640) 
[1] baseline HIV RNA level
Sexual risk group 
[Units: Participants]
Count of Participants
 
Female   11 
Heterosexual Male   9 
Men who have sex with men   72 
sexually transmitted diseases within 8 weeks prior to diagnosis [1] 
[Units: Participants]
Count of Participants
 14 
[1] Diagnosis of sexually transmitted disease within the 8 weeks prior to diagnosis with acute HIV


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Without Virologic Failure at Week 24   [ Time Frame: HIV RNA level prior to or at week 24 following enrollment ]

2.  Secondary:   Number of Participants Without Virologic Failure at Week 48   [ Time Frame: HIV RNA level at week 48 following enrollment ]

3.  Secondary:   Number of Participants With HIV RNA Suppression at Week 96   [ Time Frame: HIV RNA level at 96 weeks following enrollment ]

4.  Secondary:   Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications   [ Time Frame: At enrollment ]

5.  Secondary:   Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment   [ Time Frame: At enrollment ]

6.  Secondary:   Time 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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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
e-mail: cynthia_gay@med.unc.edu


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.

Other Publications:

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)
Study First Received: June 17, 2009
Results First Received: February 8, 2017
Last Updated: April 6, 2017