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

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ClinicalTrials.gov Identifier: NCT00090779
Recruitment Status : 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.)
First Posted : September 6, 2004
Results First Posted : December 18, 2012
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Adult AIDS Clinical Trials Group
Information provided by (Responsible Party):
AIDS Clinical Trials Group

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
Enrollment 130
Recruitment Details 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  
Arm/Group Title IT Arm DT Arm
Hide Arm/Group Description 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. 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.
Period Title: Step 1
Started 66 64
Completed 55 [1] 49 [1]
Not Completed 11 15
Reason Not Completed
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 Title: Step 2
Started 6 [1] 19 [2]
Completed 0 1
Not Completed 6 18
Reason Not Completed
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 Title: Step 3
Started 7 5
Completed 0 0
Not Completed 7 5
Reason Not Completed
Initiation of ART and off extended study             3             2
Off extended study due to study closure             4             3
Arm/Group Title IT Arm DT Arm Total
Hide Arm/Group Description IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily DT arm participants received no Treatment Total of all reporting groups
Overall Number of Baseline Participants 66 64 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 64 participants 130 participants
34.1  (11.3) 34.6  (9.1) 34.4  (10.3)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 64 participants 130 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
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 64 participants 130 participants
Female
8
  12.1%
5
   7.8%
13
  10.0%
Male
58
  87.9%
59
  92.2%
117
  90.0%
Race  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 64 participants 130 participants
White 49 56 105
Black/ African American 10 3 13
Other 4 4 8
Unknown 3 1 4
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 64 participants 130 participants
Hispanic or Latino 14 9 23
Not Hispanic or Latino 52 55 107
CD4 Counts  
Mean (Standard Deviation)
Unit of measure:  Cells/mm3
Number Analyzed 66 participants 64 participants 130 participants
570  (197) 611  (207) 590  (202)
CD4 Count Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 64 participants 130 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  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 66 participants 64 participants 130 participants
4.4  (0.6) 4.4  (0.6) 4.4  (0.6)
HIV-1 RNA Viral Load Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 64 participants 130 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
1.Primary Outcome
Title Ranked Log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at 72 and 76 Weeks for the IT Arm and DT Arm
Hide Description The primary endpoint is (i) the average of log10 viral loads (VL) at wks 72 and 76 for participants who continued to wk 72 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the “failures” who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D.
Time Frame At Weeks 72 and 76
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in follow-up at least 72 weeks since randomization were included.
Arm/Group Title IT Arm DT Arm
Hide Arm/Group Description:
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
DT arm participants received no Treatment
Overall Number of Participants Analyzed 39 40
Median (Full Range)
Unit of Measure: rank
26.0
(1.0 to 70.0)
49.3
(4.0 to 70.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IT Arm, DT Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title 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
Hide Description The primary endpoint is (i) average wk 36 and 40 VL for those who continued to wk 36 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the “failures” who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D.
Time Frame IT arm (weeks 72 and 76) and DT arm ( weeks 36 and 40)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in follow-up at least 72 weeks since randomization were included.
Arm/Group Title IT Arm DT Arm
Hide Arm/Group Description:
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
DT arm participants received no Treatment
Overall Number of Participants Analyzed 39 40
Median (Full Range)
Unit of Measure: rank
26.0
(1.0 to 70.0)
48.5
(28.0 to 67.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IT Arm, DT Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Number of Participants Experiencing Either a CDC Category B or C Diagnosis, CD4<200 Cells/mm^3 or CD4 Percent <14%.
Hide Description [Not Specified]
Time Frame 96 weeks since randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IT Arm DT Arm
Hide Arm/Group Description:
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
DT arm participants received no Treatment
Overall Number of Participants Analyzed 66 64
Measure Type: Number
Unit of Measure: participants
2 8
4.Secondary Outcome
Title Change in CD4 Counts Cells/mm^3 From Week 36 for IT Arm and From Week 0 for DT Arm
Hide Description [Not Specified]
Time Frame IT arm (weeks 36, 60, 72, 84 and 96) and DT arm (weeks 0, 24, 36, 48 and 60)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in IT arm with multidrug resistance at baseline was excluded from this analysis.
Arm/Group Title IT Arm DT Arm
Hide Arm/Group Description:
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
DT arm participants received no Treatment
Overall Number of Participants Analyzed 65 64
Mean (Standard Deviation)
Unit of Measure: Change in Log10 transformed CD4 Counts
IT arm (wk 60- wk 36) vs. DT arm (wk 24- wk 0) -0.11  (0.10) -0.02  (0.12)
IT arm (wk 72- wk 36) vs. DT arm (wk 36- wk 0) -0.10  (0.12) -0.03  (0.11)
IT arm (wk 84- wk 36) vs. DT arm (wk 48- wk 0) -0.10  (0.12) -0.06  (0.17)
IT arm (wk 96- wk 36) vs. DT arm (wk 60- wk 0) -0.12  (0.13) -0.02  (0.15)
5.Secondary Outcome
Title Number of Participants Meeting Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
Hide Description The clinical, virologic, or immunologic criteria for treatment initiation or re-initiation include CD4 count below 350 cells/mm^3 on two consecutive determinations at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, (2) confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, (3) confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or (4) CDC Category B or C diagnosis.
Time Frame 96 weeks since randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All 130 eligible subjects were included.
Arm/Group Title IT Arm DT Arm
Hide Arm/Group Description:
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
DT arm participants received no Treatment
Overall Number of Participants Analyzed 66 64
Measure Type: Number
Unit of Measure: Participants
7 23
6.Secondary Outcome
Title Number of Participants in IT Arm Off Treatment Before 36 Weeks
Hide Description The study provided fixed-dose combination emtricitabine/tenofovir DF 200/300 mg orally once daily and lopinavir/ritonavir 200/50 mg administered either as two tablets twice daily or four tablets once daily, for the first 36 weeks for individuals in the IT arm.
Time Frame At Week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All 66 eligible subjects in IT arm were included.
Arm/Group Title IT Arm
Hide Arm/Group Description:
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: participants
8
7.Secondary Outcome
Title Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
Hide Description 5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization to meeting the criteria for treatment initiation or re-initiation which include CD4 count below 350 cells/mm^3 on two consecutive measurements at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis.
Time Frame 96 weeks since randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Throughout database cutoff for DSMB review (by July 2, 2009).
Arm/Group Title IT Arm DT Arm
Hide Arm/Group Description:
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
DT arm participants received no Treatment
Overall Number of Participants Analyzed 65 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
6.3
(0 to 13.0)
6.9
(2.3 to 12.3)
10th percentile
13.0
(0 to 26.1)
12.3
(2.3 to 18.3)
25th percentile
36.4
(19.9 to 50.4)
26.3
(16.9 to 36.4)
50th percentile
72.0
(52.4 to 94.1)
60.0
(36.4 to 93.9)
75th percentile
NA [1] 
(NA to NA)
96.0
(72.0 to 96.0)
90th percentile
NA [2] 
(NA to NA)
96.0 [3] 
(96.0 to NA)
[1]
Not estimable as the estimates for survival function at all weeks is above 25%
[2]
Not estimable as the estimates for survival function at all weeks is above 10%
[3]
Not estimable as the upper limit for survival function at all weeks is above 10%
8.Secondary Outcome
Title 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
Hide Description 5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization for DT arm or from week 36 for IT arm to meeting the criteria for treatment initiation or re-initiation which include two consecutive CD4 count below 350 cells/mm^3 at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis.
Time Frame 96 weeks since randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Through database cutoff for DSMB review (by July 2, 2009). The analysis includes only those in the IT arm who continued ART through week 36 (n=49), compared to all in the DT arm (n=64).
Arm/Group Title IT Arm DT Arm
Hide Arm/Group Description:
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
DT arm participants received no Treatment
Overall Number of Participants Analyzed 65 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
5.1
(0.4 to 13.0)
6.9
(2.3 to 12.3)
10th percentile
10.4
(0.4 to 16.4)
12.3
(2.3 to 18.3)
25th percentile
22.7
(13.0 to 39.3)
26.3
(16.9 to 36.4)
50th percentile
58.1 [1] 
(36.0 to NA)
60.0
(36.4 to 93.9)
75th percentile
NA [2] 
(NA to NA)
96.0
(72.0 to 96.0)
90th percentile
NA [3] 
(NA to NA)
96.0 [4] 
(96.0 to NA)
[1]
Not estimable as the upper limit for survival function at all weeks is above 50%
[2]
Not estimable as the estimates for survival function at all weeks is above 25%
[3]
Not estimable as the estimates for survival function at all weeks is above 10%
[4]
Not estimable as the upper limit for survival function at all weeks is above 10%
9.Secondary Outcome
Title Time to Treatment Initiation or Death
Hide Description 5th, 10th, 25th, 50th and 75th percentiles in weeks from randomization to treatment initiation or death
Time Frame 5 years since randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible subjects were included except one subject in IT arm with baseline multidrug resistance.
Arm/Group Title IT Arm DT Arm
Hide Arm/Group Description:
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
DT arm participants received no Treatment
Overall Number of Participants Analyzed 65 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
36
(0 to 36.9)
13.9
(6.4 to 20.9)
10th percentile
36.9
(0 to 51.9)
20.9
(6.4 to 37.0)
25th percentile
67.1
(44.0 to 94.6)
43.7
(31.6 to 96.0)
50th percentile
96.4
(94.0 to 157.9)
97.3
(94.0 to 146.4)
75th percentile
163.3 [1] 
(97.7 to NA)
157.7 [1] 
(99.9 to NA)
[1]
Not estimable as the upper limit for survival function at all weeks is above 25%
Time Frame 5 years since randomization
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IT Arm DT Arm
Hide Arm/Group Description IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily DT arm participants received no Treatment
All-Cause Mortality
IT Arm DT Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IT Arm DT Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   1/66 (1.52%)   0/64 (0.00%) 
Investigations     
Blood bilirubin increased  1  1/66 (1.52%)  0/64 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IT Arm DT Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   58/66 (87.88%)   48/64 (75.00%) 
Blood and lymphatic system disorders     
Lymphadenopathy  1  1/66 (1.52%)  5/64 (7.81%) 
Gastrointestinal disorders     
Abdominal pain  1  3/66 (4.55%)  4/64 (6.25%) 
Diarrhoea  1  19/66 (28.79%)  10/64 (15.63%) 
Nausea  1  8/66 (12.12%)  6/64 (9.38%) 
Vomiting  1  5/66 (7.58%)  4/64 (6.25%) 
General disorders     
Fatigue  1  9/66 (13.64%)  6/64 (9.38%) 
Pyrexia  1  5/66 (7.58%)  3/64 (4.69%) 
Infections and infestations     
Upper respiratory tract infection  1  6/66 (9.09%)  4/64 (6.25%) 
Investigations     
Alanine aminotransferase increased  1  10/66 (15.15%)  15/64 (23.44%) 
Aspartate aminotransferase increased  1  8/66 (12.12%)  12/64 (18.75%) 
Blood bilirubin increased  1  7/66 (10.61%)  3/64 (4.69%) 
Blood cholesterol abnormal  1  15/66 (22.73%)  12/64 (18.75%) 
Blood cholesterol increased  1  13/66 (19.70%)  10/64 (15.63%) 
Blood glucose abnormal  1  9/66 (13.64%)  10/64 (15.63%) 
Blood glucose decreased  1  7/66 (10.61%)  5/64 (7.81%) 
Blood phosphorus decreased  1  22/66 (33.33%)  12/64 (18.75%) 
Blood triglycerides abnormal  1  4/66 (6.06%)  4/64 (6.25%) 
Blood uric acid increased  1  5/66 (7.58%)  2/64 (3.13%) 
Lipase increased  1  6/66 (9.09%)  13/64 (20.31%) 
Low density lipoprotein  1  3/66 (4.55%)  5/64 (7.81%) 
Low density lipoprotein abnormal  1  15/66 (22.73%)  17/64 (26.56%) 
Low density lipoprotein increased  1  9/66 (13.64%)  3/64 (4.69%) 
Neutrophil count decreased  1  6/66 (9.09%)  6/64 (9.38%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  1/66 (1.52%)  4/64 (6.25%) 
Nervous system disorders     
Dizziness  1  4/66 (6.06%)  2/64 (3.13%) 
Headache  1  4/66 (6.06%)  5/64 (7.81%) 
Migraine  1  4/66 (6.06%)  0/64 (0.00%) 
Psychiatric disorders     
Depression  1  6/66 (9.09%)  6/64 (9.38%) 
Respiratory, thoracic and mediastinal disorders     
Nasal congestion  1  5/66 (7.58%)  2/64 (3.13%) 
Skin and subcutaneous tissue disorders     
Night sweats  1  1/66 (1.52%)  4/64 (6.25%) 
Vascular disorders     
Hypertension  1  4/66 (6.06%)  2/64 (3.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights”.
Results Point of Contact
Name/Title: ACTG ClinicalTrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00090779     History of Changes
Other Study ID Numbers: ACTG A5217
1U01AI068636 ( U.S. NIH Grant/Contract )
AIEDRP AIN503
ACTG A5217
First Submitted: September 3, 2004
First Posted: September 6, 2004
Results First Submitted: July 2, 2012
Results First Posted: December 18, 2012
Last Update Posted: October 11, 2018