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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI068636 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The purpose of this study is to determine if pregnancy-limited, short-term combination HIV treatment regimens -- which were used solely for the prevention of mother to child transmission of HIV and discontinued postpartum -- decreases the effectiveness of a standard initial regimen of anti-HIV drugs when subsequent treatment is needed.
Stopping and restarting highly active antiretroviral therapy (HAART) is not generally recommended because it has the potential to allow drug-resistant HIV to emerge. However, to prevent mother-to-child transmission (MTCT), HIV infected women who are pregnant are temporarily put on HAART, even if HIV treatment is not indicated at the time. It is unknown if such short-term therapy affects the viral response to HAART later, when permanent therapy is clinically indicated. The purpose of this study is to determine if HAART taken to prevent MTCT during pregnancy has an effect on the ability of a standard initial regimen of HAART to suppress HIV viral load.> >>
>
>> Study follow-up will last for 48 weeks per participant. Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate. There will be 8 clinical visits in this study; visits will occur at baseline and at Weeks 2, 4, 8, 16, 24, 36, and 48. At each visit, a physical exam, blood and urine collection, and pregnancy tests will occur. At some visits, adherence, quality-of-life, and birth control interviews will be completed.>
>>
>
>> Enrollment in this study will last until 47 participants have joined or until December 31, 2009, whichever comes later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EFV + FTC/TDF | Experimental | Participants will efavirenz (600mg in pill form, taken orally, once daily) and emtricitabine/tenofovir disoproxil fumarate (200/300mg in pill form, taken orally, once daily), for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efavirenz | Drug | 600-mg tablet taken orally daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Early Virologic Response | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml | At Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Safety Event | 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. | Throughout study |
| Percentage of Participants With Early Virologic Suppression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary A. Vogler, MD | Division of Infectious Diseases, Weill College of Medicine of Cornell University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ucsd, Avrc | San Diego | California | 92103 | United States | ||
| Brigham and Women's Hospital, Division of Infectious Disease |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15595430 | Background | Abrams EJ. Prevention of mother-to-child transmission of HIV--successes, controversies and critical questions. AIDS Rev. 2004 Jul-Sep;6(3):131-43. | |
| 15000589 | Background | Bassetti D, Cargnel A. Genotypic resistance tests for the management of the HIV-infected pregnant woman. Scand J Infect Dis Suppl. 2003;106:70-4. | |
| Label | URL |
|---|---|
| Click here for more information on this network of studies | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | EFV + FTC/TDF | Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Emtricitabine/Tenofovir disoproxil fumarate | Drug | 200-mg emtricitabine/300-mg tenofovir disoproxil fumarate tablet taken orally once daily |
|
|
Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml |
| At Weeks 24 |
| Percentage of Participants With Late Virologic Response | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml | At Week 48 |
| Time to Initial Virologic Response | Time from enrollment to scheduled week of first plasma HIV-1 RNA viral load fewer than 400 copies/mL. | Throughout study |
| Time to Initial Virological Failure | 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. | Throughout study |
| Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm) | Throughout study |
| Early Changes in CD4 Count From Baseline | Changes in CD4+ lymphocyte counts between study visit weeks 4, 8 16 and 24 and baseline. | At weeks 0(baseline), 4, 8, 16, 24 |
| Percentage of Participants With Late Virologic Suppression | Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml | At Week 48 |
| Time to First Dose Modification | Time from starting study treatment to first dose/drug modification. | Throughout study |
| Late Change in CD4 Count From Baseline | Change in CD4+ lymphocyte counts between week 48 study visit and baseline. | At week 48 |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63108 | United States |
| Weill Med. College of Cornell Univ., The Cornell CTU -Chelsea | New York | New York | 10011 | United States |
| Bronx-Lebanon Hosp. Ctr. CRS | The Bronx | New York | 10457 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz | Rio de Janeiro | 21045 | Brazil |
| San Miguel CRS | San Miguel | Lima region | Peru |
| Barranco CRS | Lima | 18 | Peru |
| 17197811 |
| Background |
| Duran AS, Losso MH, Salomon H, Harris DR, Pampuro S, Soto-Ramirez LE, Duarte G, de Souza RS, Read JS; NISDI Perinatal Study Group. Drug resistance among HIV-infected pregnant women receiving antiretrovirals for prophylaxis. AIDS. 2007 Jan 11;21(2):199-205. doi: 10.1097/QAD.0b013e328011770b. |
| Primary Outcome Evaluation |
|
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | EFV + FTC/TDF | Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| CD4 count, Continuous | Mean | Standard Deviation | cells/mm^3 |
| ||||||||||||||||||||||
| CD4 count, Categorical | Number | participants |
| |||||||||||||||||||||||
| Plasma HIV-1 RNA, Continuous | Mean | Standard Deviation | log10 copies/mL |
| ||||||||||||||||||||||
| Plasma HIV-1 RNA, Categorical | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Early Virologic Response | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 24 |
|
|
| |||||||||||||||||||||||||
| Secondary | Time to First Safety Event | 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. | All enrolled participants who started study treatment (which in this case, matches the number of participants enrolled.) | Posted | Number | 95% Confidence Interval | weeks | Throughout study |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Early Virologic Suppression | Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | At Weeks 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Late Virologic Response | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml | Participants with plasma HIV-1 RNA viral load result available from week 48 study visit. | Posted | Number | 95% Confidence Interval | percentage | At Week 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Initial Virologic Response | Time from enrollment to scheduled week of first plasma HIV-1 RNA viral load fewer than 400 copies/mL. | All enrolled participants included. | Posted | Number | 95% Confidence Interval | weeks | Throughout study |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Initial Virological Failure | 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. | All participants enrolled are included. | Posted | Number | 95% Confidence Interval | weeks | Throughout study |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm) | All enrolled participants included. | Posted | Number | 95% Confidence Interval | weeks | Throughout study |
|
|
| ||||||||||||||||||||||||||
| Secondary | Early Changes in CD4 Count From Baseline | Changes in CD4+ lymphocyte counts between study visit weeks 4, 8 16 and 24 and baseline. | Intent to treat (study treatment status and history ignored); missing measurements ignored. | Posted | Mean | Standard Deviation | cells/mm^3 | At weeks 0(baseline), 4, 8, 16, 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Late Virologic Suppression | Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml | Participants with ultra-sensitive (detectable to 50 copies/mL) plasma HIV-1 RNA result available from week 48 visit. | Posted | Number | 95% Confidence Interval | percentage | At Week 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Time to First Dose Modification | Time from starting study treatment to first dose/drug modification. | All enrolled participants who started study treatment. | Posted | Number | 95% Confidence Interval | weeks | Throughout study |
|
| ||||||||||||||||||||||||||
| Secondary | Late Change in CD4 Count From Baseline | Change in CD4+ lymphocyte counts between week 48 study visit and baseline. | Participants with a CD4+ lymphocyte cell count result from the week 48 study visit. | Posted | Mean | Standard Deviation | cells/mm^3 | At week 48 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EFV+FTC/TDF | Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks | 1 | 54 | 41 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Sinusitis bacterial | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Blood cholesterol | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Low density lipoprotein abnormal | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ACTG ClinicalTrials.gov Coordinator | ACTG Network Coordinating Center, Social and Scientific Systems, Inc. | (301) 628-3313 | ACTGCT.Gov@s-3.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C098320 | efavirenz |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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| Between 31 and 35 years |
|
| Between 36 and 40 years |
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| Between 40 and 45 years |
|
| Peru |
|
| Between 100 and 199 cells/mm^3 |
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| Between 200 and 299 cells/mm^3 |
|
| Between 300 and 399 cells/mm^3 |
|
| 400 or more cells/mm^3 |
|
| Between 1001 and 10,000 copies/mL |
|
| Between 10,001 and 50,000 copies/mL |
|
| Between 50,001 and 75,000 copies/mL |
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| Between 75,001 and 250,000 copies/mL |
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| More than 250,000 copies/mL |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| 50th percentile |
| |||||
| 75th percentile |
| |||||
| 95th percentile |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| 5th percentile |
| |||||
| 10th percentile |
| |||||
| 15th percentile |
|
| Categories |
|---|
| 10th percentile |
| |||||
| 15th percentile |
| |||||
| 20th percentile |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Change from baseline to week 4 |
| |||||
| Change from baseline to week 8 |
| |||||
| Change from baseline to week 16 |
| |||||
| Change from baseline to week 24 |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories |
|---|
| 10th percentile |
| |||||
| 15th percentile |
| |||||
| 20th percentile |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|