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

• ClinicalTrials.gov Identifier: NCT00090779
• Recruitment Status: Terminated
• First Posted: September 6, 2004
• Results First Posted: December 18, 2012
• Last Update Posted: October 11, 2018
• Sponsor: AIDS Clinical Trials Group
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		IT Arm	DT Arm	Total
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
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

Outcome Measures

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
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

Outcome Measure Data

Analysis Population Description

Participants in follow-up at least 72 weeks since randomization were included.

Arm/Group Title	IT Arm	DT Arm
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)

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
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)

Outcome Measure Data

Analysis Population Description

Participants in follow-up at least 72 weeks since randomization were included.

Arm/Group Title	IT Arm	DT Arm
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)

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%.
Description	[Not Specified]
Time Frame	96 weeks since randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IT Arm	DT Arm
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
Description	[Not Specified]
Time Frame	IT arm (weeks 36, 60, 72, 84 and 96) and DT arm (weeks 0, 24, 36, 48 and 60)

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

All 130 eligible subjects were included.

Arm/Group Title	IT Arm	DT Arm
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
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

Outcome Measure Data

Analysis Population Description

All 66 eligible subjects in IT arm were included.

Arm/Group Title	IT Arm
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
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

Outcome Measure Data

Analysis Population Description

Throughout database cutoff for DSMB review (by July 2, 2009).

Arm/Group Title	IT Arm	DT Arm
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
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

Outcome Measure Data

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
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
Description	5th, 10th, 25th, 50th and 75th percentiles in weeks from randomization to treatment initiation or death
Time Frame	5 years since randomization

Outcome Measure Data

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
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%

Adverse Events

Time Frame	5 years since randomization
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	IT Arm	DT Arm
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	--/--	--/--
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
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

Limitations and Caveats

[Not Specified]

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.

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
• EMail: ACTGCT.Gov@s-3.com

Publications of Results:

Messer K, Vaida F, Hogan C. Robust analysis of biomarker data with informative missingness using a two-stage hypothesis test in an HIV treatment interruption trial: AIEDRP AIN503/ACTG A5217. Contemp Clin Trials. 2006 Dec;27(6):506-17. doi: 10.1016/j.cct.2006.07.003. Epub 2006 Jul 25.

Hogan CM, Degruttola V, Sun X, Fiscus SA, Del Rio C, Hare CB, Markowitz M, Connick E, Macatangay B, Tashima KT, Kallungal B, Camp R, Morton T, Daar ES, Little S; A5217 Study Team. The setpoint study (ACTG A5217): effect of immediate versus deferred antiretroviral therapy on virologic set point in recently HIV-1-infected individuals. J Infect Dis. 2012 Jan 1;205(1):87-96. doi: 10.1093/infdis/jir699. Epub 2011 Dec 15.

Other Publications:

Fidler S, Oxenius A, Brady M, Clarke J, Cropley I, Babiker A, Zhang HT, Price D, Phillips R, Weber J. Virological and immunological effects of short-course antiretroviral therapy in primary HIV infection. AIDS. 2002 Oct 18;16(15):2049-54. doi: 10.1097/00002030-200210180-00010.

Kassutto S, Rosenberg ES. Primary HIV type 1 infection. Clin Infect Dis. 2004 May 15;38(10):1447-53. doi: 10.1086/420745. Epub 2004 Apr 30.

Little SJ, Holte S, Routy JP, Daar ES, Markowitz M, Collier AC, Koup RA, Mellors JW, Connick E, Conway B, Kilby M, Wang L, Whitcomb JM, Hellmann NS, Richman DD. Antiretroviral-drug resistance among patients recently infected with HIV. N Engl J Med. 2002 Aug 8;347(6):385-94. doi: 10.1056/NEJMoa013552.

Pilcher CD, Eron JJ Jr, Galvin S, Gay C, Cohen MS. Acute HIV revisited: new opportunities for treatment and prevention. J Clin Invest. 2004 Apr;113(7):937-45. doi: 10.1172/JCI21540. Erratum In: J Clin Invest. 2006 Dec;116(12):3292.

• Responsible Party: AIDS Clinical Trials Group
• ClinicalTrials.gov Identifier: NCT00090779
• 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