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| ID | Type | Description | Link |
|---|---|---|---|
| U01AI068632 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This study was a randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but did not otherwise meet criteria to initiate HAART for their own health. The study was designed to determine whether continuation of HAART after delivery or other pregnancy outcome reduced morbidity and mortality compared to discontinuation and re-initiation of HAART when protocol specified criteria were met.
This randomized strategy trial addressed therapeutic questions for women from regions where antepartum HAART for PMTCT (for all CD4+ cell counts) and postpartum formula feeding is standard of care, and who also had both a pre-HAART CD4+ cell count >400 cells/mm^3 and a screening (on-HAART) CD4+ cell count > 400 cells/mm^3. For these women, the objectives related to the relative efficacy and safety of continuing HAART (when it is no longer used for PMTCT) versus discontinuing HAART.
Potential participants were identified/recruited and consented during pregnancy or after delivery or other pregnancy outcome. Study-specific screening was initiated in the third trimester or after pregnancy outcome. Women who were screened for the study were counseled to continue their HAART until they were randomized.
Randomization would occur within 0-42 days after pregnancy outcome. Women who did not carry their pregnancy to the third trimester but otherwise meet study eligibility criteria could be enrolled.
Participants were randomized to one of the two study arms:
Arm A: Continuation of HAART Arm B: Discontinuation of HAART and resume HAART when protocol-specified criteria were met
Participants were to be followed until 84 weeks after the last participant was randomized.
Key evaluations were conducted at Screening, Entry, post entry visits were scheduled to take place 4 weeks after entry, 12 weeks after entry, and every 12 weeks thereafter. Key evaluations included physical examinations, clinical assessments, and blood collection.
On 7 July 2015, the study sites received formal communications regarding the results of the Strategic Timing of Antiretroviral Treatment (START) study and associated changes were implemented to the 1077HS study in response to these results. All sites were instructed that all women in the 1077HS study were to be informed of the START study results and that antiretroviral therapy (ART) was recommended for all women based on the START study results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continue HAART | Experimental | Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome. |
|
| Stop HAART | Active Comparator | Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Highly active antiretroviral therapy (HAART) | Drug | A combination of three or more HIV medications belonging to two or more drug classes. The preferred study-supplied HAART regimen was lopinavir/ritonavir (LPV/RTV) plus fixed dose combination tenofovir/emtricitabine (TDF/FTC). Additional ARVs provided for use in this study included fixed dose combination lamivudine/zidovudine (3TC/ZDV), lamivudine (3TC), zidovudine (ZDV), tenofovir (TDF), fixed dose combination tenofovir/emtricitabine/rilpivirine (TDF/FTC/RPV), didanosine (ddI), atazanavir (ATV), raltegravir (RAL), and ritonavir (RTV). While LPV/RTV plus TDF/FTC was the preferred study-supplied regimen, the study clinicians in conjunction with participants would determine the optimal drug combination for each participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death | AIDS defining illness, serious non-AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of AIDS - Defining Illness | AIDS defining illness, refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
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Inclusion Criteria:
Women age ≥ 18 years or who had attained the minimum age of independent consent, as defined by the local Institutional Review Board (IRB), and were willing and able to provide written informed consent Additionally, at sites with IRB approval to enroll younger participants, women age 16-17 years who were willing and able to provide written assent and whose parent or legal guardian was willing and able to provide written informed consent
Confirmed HIV infection, documented by positive results from two samples collected at different time points prior to study entry, using protocol-specified tests (see protocol for more details)
Documentation of hepatitis B surface antibody (HBsAb) status and hepatitis B surface antigen (HBsAg) status (if antibody was negative) within 12 months prior to study entry
Within 0-42 days after pregnancy outcome
Antiretroviral treatment naïve, defined as < 14 days of one or more antiretroviral agents, prior to therapy initiated during current pregnancy
Receipt of at least four weeks of HAART prior to study entry, at least two weeks of which must have been prior to pregnancy outcome (up to seven consecutive days of missed therapy is permitted)
CD4+ cell count ≥ 400 cells/mm^3 on a specimen obtained within 120 days prior to initiation of HAART for current pregnancy
CD4+ cell count ≥ 400 cells/mm^3 on a specimen obtained on HAART and within 45 days prior to study entry
The following laboratory values on a specimen obtained within 45 days prior to study entry:
Estimated creatinine clearance of ≥ 60mL/min within 45 days prior to entry using the Cockcroft-Gault formula
Intent to remain in current geographical area of residence for the duration of the study
Willingness to attend study visits as required by the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith S. Currier, MD, MS | University of California, Los Angeles | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California MCA Center (5048) | Alhambra | California | 90007 | United States | ||
| David Geffen School of Medicine at UCLA (5112) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 with Clarification dated August 2009, which can be found on the DAIDS RSC Web site: http://rsc.tech-res.com | ||
| Background | Manual for Expedited Reporting of Adverse Events to DAIDS, Version 2.0, January 2010. | ||
| 28489856 | Derived | Currier JS, Britto P, Hoffman RM, Brummel S, Masheto G, Joao E, Santos B, Aurpibul L, Losso M, Pierre MF, Weinberg A, Gnanashanmugam D, Chakhtoura N, Klingman K, Browning R, Coletti A, Mofenson L, Shapiro D, Pilotto J; 1077HS PROMISE Team. Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 >/= 400 cells/mm3. PLoS One. 2017 May 10;12(5):e0176009. doi: 10.1371/journal.pone.0176009. eCollection 2017. |
| Label | URL |
|---|---|
| Related Info | View source |
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There were 1917 participants screened for the study, 264 of these failed screening and were not enrolled. The most common reasons for screening failure were CD4 cell count out of range, did not return for consent, test results unavailable on protocol specified time frame, not willing to participate, and not willing to remain on antiretrovirals.
There were 1653 participants randomized to the study with enrollments from the US, Argentina, Botswana, Brazil, China, Haiti, and Thailand. The first participant was randomized on January 2010. The last participant was randomized in November 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continue HAART | Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome. |
| FG001 | Stop HAART | Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event | Serious non - AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
| Incidence Rate of Deaths | The incidence rate was obtained by using the Kaplan-Meier method. | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
| Incidence Rate of HIV/AIDS Related Events | HIV/AIDS related events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
| Incidence Rate of HIV/AIDS Related Events or Death | HIV/AIDS related events or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
| Incidence Rate of HIV/AIDS Related Events or WHO Clinical Stage 2 or 3 Events | HIV/AIDS related events or WHO Clinical Stage 2 or 3 events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
| Incidence Rate of Grade 2 and Above Toxicity | The toxicity events included all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the Division of AIDS (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). The incidence rate was obtained by using the Kaplan-Meier method. | All laboratory measures were done at entry,4 and 12 weeks after, and then every 3 months until study end. Signs and Symptoms were recorded from study entry to study end. All were followed until July 7, 2015 (an average of 125 weeks of follow-up) |
| Incidence Rate of Cardiovascular or Other Metabolic Events | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
| Incidence Rate of Other Targeted Medical Conditions | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
| Incidence Rate of Any Condition Outlined in Appendix II of Protocol or Death | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
| Number of Virologic Failure (VF) Participants With HIV Resistance in the Continue HAART Arm | VF was defined as two successive measurements of HIV-1 RNA above 1000 copies/ml at or after 24 weeks of HAART. HIV drug resistance was defined using the Stanford database (Version 6.2) | At time of confirmation of VF. HIV-1 RNA testing to identify VF was done at week 4, 12, 24, and every 12 weeks thereafter until study end at an average of 125 weeks. If HIV-1 RNA was above 1000 copies/ml, confirmatory testing was done within 4 weeks. |
| Medication Adherence - Last Time Missed Medications | Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided. | week 0, 48 and 96 |
| Medication Adherence - How Closely Followed Schedule | Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided. | week 0, 48 and 96 |
| Medication Adherence - How Often Follow Instructions | Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided. | week 0, 48 and 96 |
| Medication Adherence - Missed Dose Within Past 4 Days | Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided. | week 0, 48 and 96 |
| Quality of Life - General Health Outcome | Quality of Life was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided. | week 0, 48 and 96 |
| Quality of Life (QoL) - Health Rating Score | QoL - health rating score was evaluated by a self reported questionnaire. Health rating score of 0 was indicative of death or worst possible health and a score of 100 was being in perfect or best possible health and the mean of score is calculated. Higher scores indicate better Quality of Life (QoL). The range is 0-100 units on a scale | week 0, 48 and 96 |
| Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. This outcome required additional funding for laboratory testing which was not available and so this outcome is not reported. | Measured at baseline, after 4 and 12 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
| Cost Effectiveness and Feasibility of Treatment Models | This outcome was intended as an exploratory analyses and was not included in the primary analyses. Given the results of the primary analyses and changes in WHO guidelines to recommend lifelong antiretroviral therapy, the protocol team decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. | Measured at baseline, after 4 - 12 and 24 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
| Los Angeles |
| California |
| 90095 |
| United States |
| UCSD Mother-Child-Adolescent HIV Program (4601) | San Diego | California | 92093 | United States |
| Harbor (UCLA) Medical Center (5045) | Torrance | California | 90505 | United States |
| University of Colorado (5052) | Aurora | Colorado | 80045 | United States |
| Howard University (5044) | Washington D.C. | District of Columbia | 20059 | United States |
| Georgetown University (1008) | Washington D.C. | District of Columbia | United States |
| Washington Hospital Center (5023) | Washington D.C. | District of Columbia | United States |
| Children's Diagnostic and Treatment Center (5055) | Fort Lauderdale | Florida | United States |
| University of Florida at Jacksonville (5051) | Jacksonville | Florida | United States |
| University of Miami Pediatric/Perinatal Clinical Research Site (4201) | Miami | Florida | United States |
| University of South Florida at Tampa (5018) | Tampa | Florida | United States |
| Ann & Robert H Lurie Children's Hospital of Chicago (4001) | Chicago | Illinois | United States |
| Tulane University (5095) | New Orleans | Louisiana | United States |
| Johns Hopkins University School of Medicine (5092) | Baltimore | Maryland | 21287 | United States |
| Boston Medical Center (5011) | Boston | Massachusetts | United States |
| Wayne State University/Children's Hospital of Michigan (5041) | Detroit | Michigan | United States |
| Metropolitan Hospital (5003) | New York | New York | 10029 | United States |
| SUNY Stony Brook University Medical Center (5040) | Stony Brook | New York | United States |
| Bronx-Lebanon Hospital Center (5114) | The Bronx | New York | United States |
| Jacobi Medical Center (5013) | The Bronx | New York | United States |
| Duke University Medical Center (4701) | Durham | North Carolina | United States |
| Pitt CRS (1001) | Pittsburgh | Pennsylvania | 15213 | United States |
| St Jude Children's Research Hospital (6501) | Memphis | Tennessee | United States |
| Baylor College of Medicine Texas Children's Hospital (3801) | Houston | Texas | United States |
| Seattle Children's Hospital (5017) | Seattle | Washington | United States |
| Hospital General de Agudos (5082) | Buenos Aires | Argentina |
| Gaborone Prevention/Treatment Clinical Research Site (12701) | Gaborone | Botswana |
| Molepolole Prevention/Treatment Clinical Research Site (12702) | Gaborone | Botswana |
| School of Medicine, University of Minas Gerais - FUNDEP (5073) | Belo Horizonte | Brazil |
| University Caxias do Sul (5084) | Caxias do Sul | Brazil |
| Hospital Nossa Senhora da Conceicao (5117) | Porto Alegre | Brazil |
| Hospital Santa Casa (5098) | Porto Alegre | Brazil |
| Hospital dos Servidores do Estado (5072) | Rio de Janeiro | Brazil |
| Hospital Geral De Nova Igaucu (5097) | Rio de Janeiro | Brazil |
| Instituto de Puericultura E Pediatria Martagao Geseira - FUJB (5071) | Rio de Janeiro | Brazil |
| Ribeirao Preto Medical School, University of Sao Paulo (5074) | São Paulo | Brazil |
| Guangxi Center for HIV/AIDS Prevention and Control (30274) | Nanning | Guangxi | China |
| Les Centres GHESKIO (30022) | Port-au-Prince | Haiti |
| IMPACTA Barranco Clinical Research Site (11301) | Lima | Peru |
| IMPACTA San Miguel Clinical Research Site (11302) | Lima | Peru |
| San Juan City Hospital (5031) | San Juan | 00927 | Puerto Rico |
| University of Puerto Rico Pediatric HIV/AIDS Research Program (6601) | San Juan | Puerto Rico |
| Siriraj Hospital Mahidol University CRS (5115) | Bangkok | Ratchathewi, | 10700 | Thailand |
| Bhumibol Adulyadej Hospital (5124) | Bangkok | Thailand |
| Prapokklao Hospital (5123) | Chanthaburi | 22000 | Thailand |
| Chiang Mai University (31784) | Chiang Mai | 50200 | Thailand |
| Chiang Rai Regional Hospital (5116) | Chiang Rai | Thailand |
| Chonburi Hospital (5125) | Chon Buri | 20000 | Thailand |
| Phayao Provincial Hospital (5122) | Phayao | 56000 | Thailand |
| WHO Case Definitions of HIV for Surveillance and Revised Clinical Staging and Immunological Classification of HIV-related Disease in Adults and Children (World Health Organization 2007). | View source |
| COMPLETED |
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| NOT COMPLETED |
|
|
All the participants who were randomized to the study with the exception of one participant who was excluded as she withdrew from the study on the day she was randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | Continue HAART | Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome. |
| BG001 | Stop HAART | Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Race/Ethnicity | Count of Participants | Participants |
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| Body Mass Index (BMI) | Baseline weight and height measure were not completed for some participants | Median | Inter-Quartile Range | kg/m^2 |
| ||||||||||||||
| WHO stage at entry | Clinical staging of HIV/AIDS by WHO definitions (WHO, 2007). Staging is based on clinical findings that guide the diagnosis, evaluation, and management of HIV/AIDS. Clinical stages are categorized as 1 through 4, progressing from primary HIV infection to advanced HIV/AIDS. These stages are defined by specific clinical conditions or symptoms as described in the reference (see the References in the Protocol Section). | Baseline WHO staging criteria was not completed for some participants. | Count of Participants | Participants |
| ||||||||||||||
| Duration of Antiretroviral therapy (ART) prior to study entry | Median | Inter-Quartile Range | weeks |
| |||||||||||||||
| ART regimen prior to entry | PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, EFV - Efavirenz, NVP - Nevirapine, RPV - Rilpivirine, NRTI - Nucleoside Reverse Transcriptase Inhibitor, II - Integrase Inhibitor | Count of Participants | Participants |
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| Hepatitis B surface antigen | Baseline Hepatitis B surface antigen was not obtained for some participants | Count of Participants | Participants |
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| Hepatitis B surface antibody | Baseline Hepatitis B surface antibody was not obtained for some participants | Count of Participants | Participants |
| |||||||||||||||
| CD4+ cell count on ART | CD4+ cell count was evaluated at screening | Median | Inter-Quartile Range | cells/mm^3 |
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| Pre-ART CD4+ cell count | Median | Inter-Quartile Range | cells/mm^3 |
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| Plasma HIV Viral Load | Baseline Plasma HIV viral load was not obtained for some participants | Count of Participants | 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 | Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death | AIDS defining illness, serious non-AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. | All participants except one who was excluded as she withdrew from study on the day she was randomized | Posted | Number | 95% Confidence Interval | New cases per 100 person - years | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
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| Secondary | Incidence Rate of AIDS - Defining Illness | AIDS defining illness, refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. | All participants except one who was excluded as she withdrew from study on the day she was randomized | Posted | Number | 95% Confidence Interval | New cases per 100 person - years | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
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| Secondary | Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event | Serious non - AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. | All participants except one who was excluded as she withdrew from study on the day she was randomized | Posted | Number | 95% Confidence Interval | New cases per 100 person - years | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
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| Secondary | Incidence Rate of Deaths | The incidence rate was obtained by using the Kaplan-Meier method. | All participants except one who was excluded as she withdrew from study on the day she was randomized | Posted | Number | 95% Confidence Interval | New cases per 100 person - years | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
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| Secondary | Incidence Rate of HIV/AIDS Related Events | HIV/AIDS related events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. | All participants except one who was excluded as she withdrew from study on the day she was randomized | Posted | Number | 95% Confidence Interval | New cases per 100 person - years | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
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| Secondary | Incidence Rate of HIV/AIDS Related Events or Death | HIV/AIDS related events or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. | All participants except one who was excluded as she withdrew from study on the day she was randomized | Posted | Number | 95% Confidence Interval | New cases per 100 person - years | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
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| Secondary | Incidence Rate of HIV/AIDS Related Events or WHO Clinical Stage 2 or 3 Events | HIV/AIDS related events or WHO Clinical Stage 2 or 3 events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. | All participants except one who was excluded as she withdrew from study on the day she was randomized | Posted | Number | 95% Confidence Interval | New cases per 100 person - years | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
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| Secondary | Incidence Rate of Grade 2 and Above Toxicity | The toxicity events included all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the Division of AIDS (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). The incidence rate was obtained by using the Kaplan-Meier method. | All participants except one who was excluded as she withdrew from study on the day she was randomized | Posted | Number | 95% Confidence Interval | New cases per 100 person - years | All laboratory measures were done at entry,4 and 12 weeks after, and then every 3 months until study end. Signs and Symptoms were recorded from study entry to study end. All were followed until July 7, 2015 (an average of 125 weeks of follow-up) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence Rate of Cardiovascular or Other Metabolic Events | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. | Posted | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence Rate of Other Targeted Medical Conditions | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. | Posted | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
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| Secondary | Incidence Rate of Any Condition Outlined in Appendix II of Protocol or Death | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. | Posted | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
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| Secondary | Number of Virologic Failure (VF) Participants With HIV Resistance in the Continue HAART Arm | VF was defined as two successive measurements of HIV-1 RNA above 1000 copies/ml at or after 24 weeks of HAART. HIV drug resistance was defined using the Stanford database (Version 6.2) | 156 women who were VFs had antiretroviral drug resistance testing performed. | Posted | Count of Participants | Participants | At time of confirmation of VF. HIV-1 RNA testing to identify VF was done at week 4, 12, 24, and every 12 weeks thereafter until study end at an average of 125 weeks. If HIV-1 RNA was above 1000 copies/ml, confirmatory testing was done within 4 weeks. |
|
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| Secondary | Medication Adherence - Last Time Missed Medications | Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided. | Participants in the Continue HAART arm who had evaluations done at the respective weeks | Posted | Count of Participants | Participants | week 0, 48 and 96 |
|
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| Secondary | Medication Adherence - How Closely Followed Schedule | Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided. | Participants in the Continue HAART arm who had evaluations done at the respective weeks | Posted | Count of Participants | Participants | week 0, 48 and 96 |
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| Secondary | Medication Adherence - How Often Follow Instructions | Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided. | Participants in the Continue HAART arm who had evaluations done at the respective weeks | Posted | Count of Participants | Participants | week 0, 48 and 96 |
|
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| Secondary | Medication Adherence - Missed Dose Within Past 4 Days | Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided. | Participants in the Continue HAART arm who had evaluations done at the respective weeks | Posted | Count of Participants | Participants | week 0, 48 and 96 |
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| Secondary | Quality of Life - General Health Outcome | Quality of Life was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided. | All participants except one who was excluded as she withdrew from study on the day she was randomized | Posted | Count of Participants | Participants | week 0, 48 and 96 |
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| Secondary | Quality of Life (QoL) - Health Rating Score | QoL - health rating score was evaluated by a self reported questionnaire. Health rating score of 0 was indicative of death or worst possible health and a score of 100 was being in perfect or best possible health and the mean of score is calculated. Higher scores indicate better Quality of Life (QoL). The range is 0-100 units on a scale | All participants except one who was excluded as she withdrew from study on the day she was randomized | Posted | Mean | Standard Deviation | units on a scale | week 0, 48 and 96 |
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| Secondary | Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. This outcome required additional funding for laboratory testing which was not available and so this outcome is not reported. | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. This outcome required additional funding for laboratory testing which was not available and so this outcome is not reported. | Posted | Measured at baseline, after 4 and 12 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
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| Secondary | Cost Effectiveness and Feasibility of Treatment Models | This outcome was intended as an exploratory analyses and was not included in the primary analyses. Given the results of the primary analyses and changes in WHO guidelines to recommend lifelong antiretroviral therapy, the protocol team decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. | This outcome was intended as an exploratory analyses and was not included in the primary analyses. Given the results of the primary analyses and changes in WHO guidelines to recommend lifelong antiretroviral therapy, the protocol team decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. | Posted | Measured at baseline, after 4 - 12 and 24 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). |
|
From study entry to off study date (an average of 125 weeks of follow-up).
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of >=Grade 3 (with exceptions to all grades of creatinine and all grade >=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continue HAART | Participants would continue receiving HAART after delivery or other pregnancy outcome. Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes | 2 | 827 | 10 | 827 | 778 | 827 |
| EG001 | Stop HAART | Participants would stop receiving HAART after delivery or other pregnancy outcome and resume when protocol-specified criteria were met. Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes | 4 | 825 | 3 | 825 | 765 | 825 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endophthalmitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Ergot poisoning | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Abortion incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
| |
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
| |
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Cervicitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood glucose abnormal | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Allen, Director, IMPAACT Operations Center | Family Health International (FHI 360) | (919) 405-1429 | mallen@fhi360.org |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D023241 | Antiretroviral Therapy, Highly Active |
| ID | Term |
|---|---|
| D004359 | Drug Therapy, Combination |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
|
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| Argentina |
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| United States |
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| Botswana |
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| China |
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| Brazil |
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| Thailand |
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| Peru |
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| HAART including non-boosted PI |
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| HAART including NNRTI [EFV] |
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| HAART including NNRTI [NVP] |
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| HAART including NNRTI [RPV] |
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| HAART including NNRTI and PI |
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| Three or more NRTIs |
|
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| Zero NRTIs |
|
|
| HAART including II |
|
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| HAART including PI and II |
|
|
|
| Negative |
|
|
| Indeterminate |
|
|
| Not obtained, Hep B antibody +ve |
|
|
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| Negative |
|
|
| Indeterminate |
|
|
| Not obtained, Hep B antibody +ve |
|
|
|
|
|
| 400 - <1000 copies/ml |
|
|
| 1000- <10000 copies/ml |
|
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| 10000-<100000 copies/ml |
|
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| >=100000 copies/ml |
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Title | Denominators | Categories | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 0 |
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| Week 48 |
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| Week 96 |
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| Title | Denominators | Categories | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 0 |
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| Week 48 |
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| Week 96 |
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| Title | Denominators | Categories | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 0 |
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| Week 48 |
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| Week 96 |
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| Title | Denominators | Categories | ||||||
|---|---|---|---|---|---|---|---|---|
| Week 0 |
|
| ||||||
| Week 48 |
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| ||||||
| Week 96 |
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| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| No special instructions |
|
| No special instructions |
|
| Very good |
|
| Good |
|
| Fair |
|
| Poor |
|
| Very good |
|
| Good |
|
| Fair |
|
| Poor |
|