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:
Collaborators:
Adult AIDS Clinical Trials Group
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00090779
First received: September 3, 2004
Last updated: November 16, 2012
Last verified: November 2012
Results First Received: July 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Emtricitabine/ tenofovir disoproxil fumarate
Drug: Lopinavir/Ritonavir

  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
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
  Hide 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.
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  
Number of Participants  
[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┬ácopies/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
  Hide Other Adverse Events

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     48/64  
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
  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
No text entered.


  More Information