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FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir

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ClinicalTrials.gov Identifier: NCT01777997
Recruitment Status : Completed
First Posted : January 29, 2013
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV-1 Infection
Intervention: Drug: Emtricitabine/rilpivirine/tenofovir disoproxil fumarate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited at 19 Clinical Research Sites (CRSs) in the United States between April 25, 2013 and December 22, 2014.

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

Reporting Groups
  Description
FTC/RPV/TDF

Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily. Participants in the primary outcome analysis were on ART for at least 24 weeks and up to 48 weeks.

Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment. Participants in exploratory analyses were on ART for at least 72 weeks and up to 96 weeks.


Participant Flow for 3 periods

Period 1:   12 Week lead-in of no ART
    FTC/RPV/TDF
STARTED   38 
COMPLETED   36 
NOT COMPLETED   2 
Severe debilitation                2 

Period 2:   Weeks 0 to 24/48 on ART
    FTC/RPV/TDF
STARTED   36 
COMPLETED   35 [1] 
NOT COMPLETED   1 
Participant felt treatment not working                1 
[1] 7 of these participants opted not to continue ART into next period

Period 3:   Weeks 48 to 72/96 on ART
    FTC/RPV/TDF
STARTED   28 
COMPLETED   26 
NOT COMPLETED   2 
Death                1 
Took prohibited/precautionary meds                1 



  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.
Participants who were on intervention (ART) for at least 24 weeks

Reporting Groups
  Description
FTC/RPV/TDF

Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.

Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment.


Baseline Measures
   FTC/RPV/TDF 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 47 
 (32 to 54) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  42.9% 
Male      20  57.1% 
Race/Ethnicity, Customized 
[Units: Participants]
 
White non-Hispanic   6 
Black non-Hispanic   26 
Hispanic (regardless of race)   3 
Region of Enrollment 
[Units: Participants]
 
United States   35 
CD4+ T-cell count [1] 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
 682 
 (564 to 1003) 
[1] Baseline CD4+ T-cell count is the mean of the two measurements obtained prior to the start of ART (study entry and study week 12).
HIV-1 RNA by Abbott Assay 
[Units: Participants]
Count of Participants
 
Pre-ART (study entry)   
<40 copies/mL      16  45.7% 
>=40 copies/mL      19  54.3% 
Week 0 on ART (study week 12)   
<40 copies/mL      13  37.1% 
>=40 copies/mL      22  62.9% 
Percentage of CD8+ T-cells that are CD38+HLA-DR+ [1] 
[Units: % of CD8+ T-cells]
Median (Inter-Quartile Range)
 24.6 
 (19.6 to 33.4) 
[1] Baseline CD8+ T-cell activation is the mean of the two measurements obtained prior to the start of ART (study entry and study week 12).
Percentage of CD4+ T-cells that are CD38+HLA-DR+ [1] 
[Units: % of CD4+ T-cells]
Median (Inter-Quartile Range)
 2.6 
 (2.2 to 4.1) 
[1] Baseline CD4+ T-cell activation is the mean of the two measurements obtained prior to the start of ART (study entry and study week 12).
Interleukin (IL)-6 [1] 
[Units: log10(pg/mL)]
Median (Inter-Quartile Range)
 0.17 
 (0.08 to 0.38) 
[1] Baseline IL-6 is the mean of the two log10-transformed measurements obtained prior to the start of ART (study entry and study week 12).
D-dimer [1] 
[Units: log10(ng/mL)]
Median (Inter-Quartile Range)
 2.58 
 (2.39 to 2.82) 
[1] Baseline D-dimer is the mean of the two log10-transformed measurements obtained prior to the start of ART (study entry and study week 12).
Quality of life (QoL) index [1] 
[Units: Units on a scale]
Median (Inter-Quartile Range)
 0.2 
 (0.1 to 0.3) 
[1] QoL index was obtained by averaging the five responses on the Euro-Quality of Life questionnaire (EQ-5D), where a response of 0 indicates "no problems/no discomfort", 1 indicates "some problems/moderate discomfort" and 2 indicates "unable to perform activities/extreme discomfort". Baseline QoL index is the mean of the two averages obtained prior to the start of ART (study entry and study week 12).


  Outcome Measures

1.  Primary:   Change in Levels of CD8+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) From Baseline to Weeks 24 and 48 on ART   [ Time Frame: From baseline (pre-ART and week 0 on ART) to weeks 24 and 48 on ART ]

2.  Secondary:   Plasma HIV-1 RNA Level Measured by Single Copy Assay Using Primer in Integrase (iSCA) as the Proportion of Participants Below the Limit of the Assay   [ Time Frame: At pre-ART and weeks 0, 4, 12, 24, 36 and 48 on ART ]

3.  Secondary:   Change in CD4+ T-cell Count   [ Time Frame: From baseline (pre-ART and week 0 on ART) to weeks 12, 24, 36 and 48 on ART ]

4.  Secondary:   Change in Levels of CD8+ T-cell Activation   [ Time Frame: From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART ]

5.  Secondary:   Change in Levels of CD4+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+)   [ Time Frame: From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART ]

6.  Secondary:   Change in Levels of Interleukin (IL)-6   [ Time Frame: From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART ]

7.  Secondary:   Change in Levels of D-dimer   [ Time Frame: From baseline (pre-ART and week 0 on ART) to weeks 4, 24 and 48 on ART ]

8.  Secondary:   Change in Quality of Life (QoL) Index   [ Time Frame: From baseline (pre-ART and week 0 on ART) to weeks 4, 24 and 48 on ART ]

9.  Secondary:   Number of Subjects Who Experience Grade 3 or 4 Signs and Symptoms or Laboratory Abnormalities, Diagnoses (Any Grade), or Other Serious Adverse Events (SAEs)   [ Time Frame: From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation ]


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
phone: (301) 628-3313
e-mail: ACTGCT.Gov@s-3.com



Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01777997     History of Changes
Other Study ID Numbers: ACTG A5308
1U01AI068636 ( U.S. NIH Grant/Contract )
First Submitted: January 10, 2013
First Posted: January 29, 2013
Results First Submitted: October 31, 2017
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018