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Trial record 10 of 31 for:    " February 14, 2007":" March 16, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV (Nearly Naive)

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ClinicalTrials.gov Identifier: NCT00442962
Recruitment Status : Completed
First Posted : March 5, 2007
Results First Posted : August 9, 2011
Last Update Posted : October 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 Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Efavirenz
Drug: Emtricitabine/Tenofovir disoproxil fumarate
Enrollment 54

Recruitment Details Study participants were recruited at 8 sites from 3 countries: 6 in the US, 1 in Brazil, 1 in Peru, between May 2007 to December 2009.
Pre-assignment Details HIV-infected women, at least 16 years of age, whose only prior exposure to anti-retrovirals (ARVs) was for the purpose of prevention of mother-to-child transmission, who now qualify to start ARVs for their own health.
Arm/Group Title EFV + FTC/TDF
Hide Arm/Group Description Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
Period Title: Overall Study
Started 54
Primary Outcome Evaluation 52 [1]
Completed 46 [2]
Not Completed 8
Reason Not Completed
Pregnancy             1
Lost to Follow-up             7
[1]
Primary outcome evaluation at week 24.
[2]
Completed 48 weeks of follow-up.
Arm/Group Title EFV + FTC/TDF
Hide Arm/Group Description Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants
29  (7)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
Between 19 and 25 years 19
Between 26 and 30 years 16
Between 31 and 35 years 9
Between 36 and 40 years 6
Between 40 and 45 years 4
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
54
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
United States 12
Brazil 22
Peru 20
CD4 count, Continuous  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 54 participants
264  (104)
CD4 count, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
< 50 cells/mm^3 1
Between 50 and 99 cells/mm^3 0
Between 100 and 199 cells/mm^3 15
Between 200 and 299 cells/mm^3 18
Between 300 and 399 cells/mm^3 15
400 or more cells/mm^3 5
Plasma HIV-1 RNA, Continuous  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 54 participants
4.5  (0.6)
Plasma HIV-1 RNA, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
<= 400 copies/mL 0
Between 401 and 1000 copies/mL 1
Between 1001 and 10,000 copies/mL 8
Between 10,001 and 50,000 copies/mL 20
Between 50,001 and 75,000 copies/mL 11
Between 75,001 and 250,000 copies/mL 12
More than 250,000 copies/mL 2
1.Primary Outcome
Title Percentage of Participants With Early Virologic Response
Hide Description Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml
Time Frame At Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ignoring current study treatment status or history); closest measurement to week 24 used; missing measurements ignored. Exact binomial confidence interval calculated using method of Blyth-Still-Casella.
Arm/Group Title EFV + FTC/TDF
Hide Arm/Group Description:
Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
Overall Number of Participants Analyzed 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
80.8
(67.8 to 90.4)
2.Secondary Outcome
Title Time to First Safety Event
Hide Description Time from starting study treatment to first grade 3 or 4 sign/symptom or laboratory abnormality and at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.
Time Frame Throughout study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who started study treatment (which in this case, matches the number of participants enrolled.)
Arm/Group Title EFV + FTC/TDF
Hide Arm/Group Description:
Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
Overall Number of Participants Analyzed 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
4.1
(0.9 to 24.4)
10th percentile
24.4 [1] 
(0.9 to NA)
15th percentile
33.1 [2] 
(4.1 to NA)
[1]
Not estimable as the upper limit for survival function at all weeks is above 90%
[2]
Not estimable as the upper limit for survival function at all weeks is above 85%
3.Secondary Outcome
Title Percentage of Participants With Early Virologic Suppression
Hide Description Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml
Time Frame At Weeks 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (ignoring current study treatment status and history); missing values ignored and closest value to week 24 used if multiple results available. 2 fewer results available compared to primary outcome b/c testing by ultrasensitive assay may have been retrospective.
Arm/Group Title EFV + FTC/TDF
Hide Arm/Group Description:
Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
72.0
(58.7 to 83.8)
4.Secondary Outcome
Title Percentage of Participants With Late Virologic Response
Hide Description Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml
Time Frame At Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with plasma HIV-1 RNA viral load result available from week 48 study visit.
Arm/Group Title EFV + FTC/TDF
Hide Arm/Group Description:
Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
Overall Number of Participants Analyzed 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
80.43
(67.1 to 89.7)
5.Secondary Outcome
Title Time to Initial Virologic Response
Hide Description Time from enrollment to scheduled week of first plasma HIV-1 RNA viral load fewer than 400 copies/mL.
Time Frame Throughout study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants included.
Arm/Group Title EFV + FTC/TDF
Hide Arm/Group Description:
Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
Overall Number of Participants Analyzed 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
50th percentile
2
(2 to 4)
75th percentile
8
(4 to 16)
95th percentile
24 [1] 
(16 to NA)
[1]
Not estimable as the upper limit for survival function at all weeks is above 95%
6.Secondary Outcome
Title Time to Initial Virological Failure
Hide Description Virologic failure defined as two consecutive measurements of plasma HIV-1 RNA at least 400 copies/mL at or after the week 16 study visit. Time measured from enrollment.
Time Frame Throughout study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled are included.
Arm/Group Title EFV + FTC/TDF
Hide Arm/Group Description:
Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
Overall Number of Participants Analyzed 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
16
(16 to 16)
10th percentile
16
(16 to 36)
15th percentile
24 [1] 
(16 to NA)
[1]
Not estimable as the upper limit for survival function at all weeks is above 85%
7.Secondary Outcome
Title Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm)
Hide Description [Not Specified]
Time Frame Throughout study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants included.
Arm/Group Title EFV + FTC/TDF
Hide Arm/Group Description:
Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
Overall Number of Participants Analyzed 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
10th percentile
16
(0 to 24)
15th percentile
24
(0 to 36)
20th percentile
24 [1] 
(4 to NA)
[1]
Not estimable as the upper limit for survival function at all weeks is above 80%
8.Secondary Outcome
Title Early Changes in CD4 Count From Baseline
Hide Description Changes in CD4+ lymphocyte counts between study visit weeks 4, 8 16 and 24 and baseline.
Time Frame At weeks 0(baseline), 4, 8, 16, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (study treatment status and history ignored); missing measurements ignored.
Arm/Group Title EFV + FTC/TDF
Hide Arm/Group Description:
Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
Change from baseline to week 4 105  (108)
Change from baseline to week 8 118  (87)
Change from baseline to week 16 138  (112)
Change from baseline to week 24 147  (147)
9.Secondary Outcome
Title Percentage of Participants With Late Virologic Suppression
Hide Description Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml
Time Frame At Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with ultra-sensitive (detectable to 50 copies/mL) plasma HIV-1 RNA result available from week 48 visit.
Arm/Group Title EFV + FTC/TDF
Hide Arm/Group Description:
Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
70.5
(55.8 to 82.1)
10.Secondary Outcome
Title Time to First Dose Modification
Hide Description Time from starting study treatment to first dose/drug modification.
Time Frame Throughout study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who started study treatment.
Arm/Group Title EFV + FTC/TDF
Hide Arm/Group Description:
Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
Overall Number of Participants Analyzed 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
10th percentile
1.9
(0.4 to 25.7)
15th percentile
24.9
(1.1 to 39.1)
20th percentile
25.7 [1] 
(1.9 to NA)
[1]
Not estimable as the upper limit for survival function at all weeks is above 80%
11.Secondary Outcome
Title Late Change in CD4 Count From Baseline
Hide Description Change in CD4+ lymphocyte counts between week 48 study visit and baseline.
Time Frame At week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with a CD4+ lymphocyte cell count result from the week 48 study visit.
Arm/Group Title EFV + FTC/TDF
Hide Arm/Group Description:
Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
Overall Number of Participants Analyzed 46
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
194  (185)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EFV+FTC/TDF
Hide Arm/Group Description Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
All-Cause Mortality
EFV+FTC/TDF
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
EFV+FTC/TDF
Affected / at Risk (%)
Total   1/54 (1.85%) 
Psychiatric disorders   
Suicide attempt  1  1/54 (1.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
EFV+FTC/TDF
Affected / at Risk (%)
Total   41/54 (75.93%) 
Gastrointestinal disorders   
Diarrhoea  1  4/54 (7.41%) 
Nausea  1  6/54 (11.11%) 
Vomiting  1  5/54 (9.26%) 
General disorders   
Pyrexia  1  5/54 (9.26%) 
Immune system disorders   
Drug hypersensitivity  1  3/54 (5.56%) 
Infections and infestations   
Sinusitis bacterial  1  4/54 (7.41%) 
Urinary tract infection  1  5/54 (9.26%) 
Vulvovaginal candidiasis  1  6/54 (11.11%) 
Investigations   
Alanine aminotransferase increased  1  5/54 (9.26%) 
Aspartate aminotransferase increased  1  7/54 (12.96%) 
Blood alkaline phosphatase increased  1  4/54 (7.41%) 
Blood cholesterol  1  4/54 (7.41%) 
Haemoglobin decreased  1  6/54 (11.11%) 
Low density lipoprotein abnormal  1  4/54 (7.41%) 
Neutrophil count decreased  1  6/54 (11.11%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity  1  3/54 (5.56%) 
Nervous system disorders   
Dizziness  1  6/54 (11.11%) 
Headache  1  7/54 (12.96%) 
Somnolence  1  5/54 (9.26%) 
Psychiatric disorders   
Abnormal dreams  1  7/54 (12.96%) 
Insomnia  1  4/54 (7.41%) 
Renal and urinary disorders   
Dysuria  1  4/54 (7.41%) 
Reproductive system and breast disorders   
Vaginal discharge  1  6/54 (11.11%) 
Vulvovaginal pruritus  1  3/54 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Nasal congestion  1  4/54 (7.41%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  8/54 (14.81%) 
Pruritus generalised  1  3/54 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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 Trial 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: NCT00442962     History of Changes
Other Study ID Numbers: ACTG A5227
1U01AI068636 ( U.S. NIH Grant/Contract )
First Submitted: March 2, 2007
First Posted: March 5, 2007
Results First Submitted: July 13, 2011
Results First Posted: August 9, 2011
Last Update Posted: October 12, 2018