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Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV

This study has been terminated.
(The DSMB concluded that the findings regarding the primary analysis would persist and that no additional study goals would be achieved by continuing the study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00090779
First Posted: September 6, 2004
Last Update Posted: December 18, 2012
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.
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Adult AIDS Clinical Trials Group
Information provided by (Responsible Party):
AIDS Clinical Trials Group
Results First Submitted: July 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Emtricitabine/ tenofovir disoproxil fumarate
Drug: Lopinavir/Ritonavir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited across 27 study sites (25 in the US and 2 in Peru) in the AIDS Clinical Trials Group system between February 2005 and June 2009.

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
IT Arm On step 1, IT arm participants received 36 weeks of emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily. Participants in IT arm who met clinical, virologic or immunologic criteria for treatment re-initiation entered step 2 and re-initiated ART. At the time of the end of original randomized study, study participants in IT arm who did not enter Step 2 and did not initiate ART without meeting eligibility criteria for Step 2 had the opportunity to take part in a long-term follow-up study (step 3) for up to a total duration of five years in order to ascertain information about HIV-1 RNA, CD4+ T-cell count, occurrence of CDC Category B or C diagnoses, and initiation of ART.
DT Arm On step 1, DT arm participants received no Treatment,unless subsequent disease progression criteria were met. Participants in DT arm who met clinical, virologic or immunologic criteria for treatment initiation entered step 2 and initiated ART. At the time of the end of original randomized study, study participants in DT arm who did not enter Step 2 and did not initiate ART without meeting eligibility criteria for Step 2 had the opportunity to take part in a long-term follow-up study (step 3) for up to a total duration of five years in order to ascertain information about HIV-1 RNA, CD4+ T-cell count, occurrence of CDC Category B or C diagnoses, and initiation of ART.

Participant Flow for 3 periods

Period 1:   Step 1
    IT Arm   DT Arm
STARTED   66   64 
COMPLETED   55 [1]   49 [1] 
NOT COMPLETED   11   15 
Withdrawal by Subject                4                2 
Lost to Follow-up                3                2 
Death                0                2 
Physician Decision                1                0 
Pregnancy                1                0 
Non-compliance to study requirements                0                1 
Subject relocated                2                8 
[1] Results are based on the database frozen on July 2, 2009 per DSMB recommendation of study closure.

Period 2:   Step 2
    IT Arm   DT Arm
STARTED   6 [1]   19 [2] 
COMPLETED   0   1 
NOT COMPLETED   6   18 
Off study per study closure                6                16 
Subject relocated                0                1 
Non-compliance to study requirements                0                1 
[1] One subject who had two consecutive CD4<350cells/mm^3 did not enter step 2.
[2] Three with two consecutive CD4<350cells/mm^3 and one with CDC category B event didn't enter step 2.

Period 3:   Step 3
    IT Arm   DT Arm
STARTED   7   5 
COMPLETED   0   0 
NOT COMPLETED   7   5 
Initiation of ART and off extended study                3                2 
Off extended study due to study closure                4                3 



  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
IT Arm IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
DT Arm DT arm participants received no Treatment
Total Total of all reporting groups

Baseline Measures
   IT Arm   DT Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 66   64   130 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.1  (11.3)   34.6  (9.1)   34.4  (10.3) 
Age, Customized 
[Units: Participants]
     
<20 years   4   0   4 
20-29 years   24   23   47 
30-39 years   19   21   40 
40-49 years   12   16   28 
50-59 years   4   4   8 
60-69 years   3   0   3 
Gender 
[Units: Participants]
     
Female   8   5   13 
Male   58   59   117 
Race 
[Units: Participants]
     
White   49   56   105 
Black/ African American   10   3   13 
Other   4   4   8 
Unknown   3   1   4 
Ethnicity 
[Units: Participants]
     
Hispanic or Latino   14   9   23 
Not Hispanic or Latino   52   55   107 
CD4 Counts 
[Units: Cells/mm3]
Mean (Standard Deviation)
 570  (197)   611  (207)   590  (202) 
CD4 Count Category 
[Units: Participants]
     
201-350 cells/mm^3   4   2   6 
351-500 cells/mm^3   26   24   50 
>500 cells/mm^3   36   38   74 
Log10 HIV-1 RNA Viral Load 
[Units: Log10 copies/mL]
Mean (Standard Deviation)
 4.4  (0.6)   4.4  (0.6)   4.4  (0.6) 
HIV-1 RNA Viral Load Category 
[Units: Participants]
     
200-399 copies/mL   0   1   1 
400-999 copies/mL   1   0   1 
1000-9999 copies/mL   16   15   31 
>=10000 copies/mL   49   48   97 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Ranked Log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at 72 and 76 Weeks for the IT Arm and DT Arm   [ Time Frame: At Weeks 72 and 76 ]

2.  Primary:   Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 72 and 76 for the IT Arm and Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 36 and 40 for the DT Arm   [ Time Frame: IT arm (weeks 72 and 76) and DT arm ( weeks 36 and 40) ]

3.  Primary:   Number of Participants Experiencing Either a CDC Category B or C Diagnosis, CD4<200 Cells/mm^3 or CD4 Percent <14%.   [ Time Frame: 96 weeks since randomization ]

4.  Secondary:   Change in CD4 Counts Cells/mm^3 From Week 36 for IT Arm and From Week 0 for DT Arm   [ Time Frame: IT arm (weeks 36, 60, 72, 84 and 96) and DT arm (weeks 0, 24, 36, 48 and 60) ]

5.  Secondary:   Number of Participants Meeting Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation   [ Time Frame: 96 weeks since randomization ]

6.  Secondary:   Number of Participants in IT Arm Off Treatment Before 36 Weeks   [ Time Frame: At Week 36 ]

7.  Secondary:   Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation   [ Time Frame: 96 weeks since randomization ]

8.  Secondary:   Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation   [ Time Frame: 96 weeks since randomization ]

9.  Secondary:   Time to Treatment Initiation or Death   [ Time Frame: 5 years since randomization ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame 5 years since randomization
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
IT Arm IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
DT Arm DT arm participants received no Treatment

Other Adverse Events
    IT Arm   DT Arm
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   58/66 (87.88%)   48/64 (75.00%) 
Blood and lymphatic system disorders     
Lymphadenopathy † 1     
# participants affected / at risk   1/66 (1.52%)   5/64 (7.81%) 
Gastrointestinal disorders     
Abdominal pain † 1     
# participants affected / at risk   3/66 (4.55%)   4/64 (6.25%) 
Diarrhoea † 1     
# participants affected / at risk   19/66 (28.79%)   10/64 (15.63%) 
Nausea † 1     
# participants affected / at risk   8/66 (12.12%)   6/64 (9.38%) 
Vomiting † 1     
# participants affected / at risk   5/66 (7.58%)   4/64 (6.25%) 
General disorders     
Fatigue † 1     
# participants affected / at risk   9/66 (13.64%)   6/64 (9.38%) 
Pyrexia † 1     
# participants affected / at risk   5/66 (7.58%)   3/64 (4.69%) 
Infections and infestations     
Upper respiratory tract infection † 1     
# participants affected / at risk   6/66 (9.09%)   4/64 (6.25%) 
Investigations     
Alanine aminotransferase increased † 1     
# participants affected / at risk   10/66 (15.15%)   15/64 (23.44%) 
Aspartate aminotransferase increased † 1     
# participants affected / at risk   8/66 (12.12%)   12/64 (18.75%) 
Blood bilirubin increased † 1     
# participants affected / at risk   7/66 (10.61%)   3/64 (4.69%) 
Blood cholesterol abnormal † 1     
# participants affected / at risk   15/66 (22.73%)   12/64 (18.75%) 
Blood cholesterol increased † 1     
# participants affected / at risk   13/66 (19.70%)   10/64 (15.63%) 
Blood glucose abnormal † 1     
# participants affected / at risk   9/66 (13.64%)   10/64 (15.63%) 
Blood glucose decreased † 1     
# participants affected / at risk   7/66 (10.61%)   5/64 (7.81%) 
Blood phosphorus decreased † 1     
# participants affected / at risk   22/66 (33.33%)   12/64 (18.75%) 
Blood triglycerides abnormal † 1     
# participants affected / at risk   4/66 (6.06%)   4/64 (6.25%) 
Blood uric acid increased † 1     
# participants affected / at risk   5/66 (7.58%)   2/64 (3.13%) 
Lipase increased † 1     
# participants affected / at risk   6/66 (9.09%)   13/64 (20.31%) 
Low density lipoprotein † 1     
# participants affected / at risk   3/66 (4.55%)   5/64 (7.81%) 
Low density lipoprotein abnormal † 1     
# participants affected / at risk   15/66 (22.73%)   17/64 (26.56%) 
Low density lipoprotein increased † 1     
# participants affected / at risk   9/66 (13.64%)   3/64 (4.69%) 
Neutrophil count decreased † 1     
# participants affected / at risk   6/66 (9.09%)   6/64 (9.38%) 
Musculoskeletal and connective tissue disorders     
Myalgia † 1     
# participants affected / at risk   1/66 (1.52%)   4/64 (6.25%) 
Nervous system disorders     
Dizziness † 1     
# participants affected / at risk   4/66 (6.06%)   2/64 (3.13%) 
Headache † 1     
# participants affected / at risk   4/66 (6.06%)   5/64 (7.81%) 
Migraine † 1     
# participants affected / at risk   4/66 (6.06%)   0/64 (0.00%) 
Psychiatric disorders     
Depression † 1     
# participants affected / at risk   6/66 (9.09%)   6/64 (9.38%) 
Respiratory, thoracic and mediastinal disorders     
Nasal congestion † 1     
# participants affected / at risk   5/66 (7.58%)   2/64 (3.13%) 
Skin and subcutaneous tissue disorders     
Night sweats † 1     
# participants affected / at risk   1/66 (1.52%)   4/64 (6.25%) 
Vascular disorders     
Hypertension † 1     
# participants affected / at risk   4/66 (6.06%)   2/64 (3.13%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 14.0



  Limitations and Caveats
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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