A Phase 4 interventional study of Highly active antiretroviral therapy (HAART) in HIV Infection, sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group. Completed at 50 sites in 9 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Phase 4, Interventional, and Treatment
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 1,653 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →International Maternal Pediatric Adolescent AIDS Clinical Trials Group is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The following laboratory values on a specimen obtained within 45 days prior to study entry:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
Drug: Highly active antiretroviral therapy (HAART)
Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Drug: Highly active antiretroviral therapy (HAART)
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.
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.
Time frame: 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 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.
Time frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
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.
| Milestone | Continue HAART | Stop HAART |
|---|---|---|
| Started | 828 | 825 |
| Completed | 691 | 699 |
| Not completed | 137 | 126 |
| Withdrew: Death | 2 | 4 |
| Withdrew: Withdrawal by subject | 35 | 31 |
| Withdrew: Lost to follow-up | 45 | 39 |
| Withdrew: Site closed | 55 | 52 |
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.
| New cases per 100 person - years | Continue HAART | Stop HAART |
|---|---|---|
| Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death | 0.21 (0.16 to 0.27) | 0.31 (0.25 to 0.38) |
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.
| New cases per 100 person - years | Continue HAART | Stop HAART |
|---|---|---|
| Incidence Rate of AIDS - Defining Illness | 0.10 (0.08 to 0.14) | 0.15 (0.12 to 0.19) |
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.
| New cases per 100 person - years | Continue HAART | Stop HAART |
|---|---|---|
| Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event | 0 (0 to 0) | 0 (0 to 0) |
The incidence rate was obtained by using the Kaplan-Meier method.
| New cases per 100 person - years | Continue HAART | Stop HAART |
|---|---|---|
| Incidence Rate of Deaths | 0.10 (0.08 to 0.14) | 0.20 (0.17 to 0.25) |
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.
| New cases per 100 person - years | Continue HAART | Stop HAART |
|---|---|---|
| Incidence Rate of HIV/AIDS Related Events | 1.32 (1.07 to 1.62) | 1.42 (1.16 to 1.73) |
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.
| New cases per 100 person - years | Continue HAART | Stop HAART |
|---|---|---|
| Incidence Rate of HIV/AIDS Related Events or Death | 1.42 (1.16 to 1.75) | 1.57 (1.30 to 1.91) |
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.
| New cases per 100 person - years | Continue HAART | Stop HAART |
|---|---|---|
| Incidence Rate of HIV/AIDS Related Events or WHO Clinical Stage 2 or 3 Events | 3.09 (2.52 to 3.79) | 5.37 (4.60 to 6.28) |
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.
| New cases per 100 person - years | Continue HAART | Stop HAART |
|---|---|---|
| Incidence Rate of Grade 2 and Above Toxicity | 18.4 (15.7 to 21.4) | 15.6 (13.2 to 18.4) |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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)
| Participants | Continue HAART |
|---|---|
| Number of Virologic Failure (VF) Participants With HIV Resistance in the Continue HAART Arm | 19 |
Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.
| Participants | Continue HAART |
|---|---|
| Week 0 — Never skipped medications | 489 |
| Week 0 — More than 1 month ago | 60 |
| Week 0 — Within the past 4 weeks | 123 |
| Week 48 — Never skipped medications | 411 |
| Week 48 — More than 1 month ago | 97 |
| Week 48 — Within the past 4 weeks | 144 |
| Week 96 — Never skipped medications | 399 |
| Week 96 — More than 1 month ago | 92 |
| Week 96 — Within the past 4 weeks | 147 |
Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.
| Participants | Continue HAART |
|---|---|
| Week 0 — Never | 23 |
| Week 0 — Some of the time | 130 |
| Week 0 — All of the time | 520 |
| Week 48 — Never | 17 |
| Week 48 — Some of the time | 173 |
| Week 48 — All of the time | 461 |
| Week 96 — Never | 25 |
| Week 96 — Some of the time | 153 |
| Week 96 — All of the time | 459 |
Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.
| Participants | Continue HAART |
|---|---|
| Week 0 — Never | 10 |
| Week 0 — Some of the time | 52 |
| Week 0 — All of the time | 166 |
| Week 0 — No special instructions | 439 |
| Week 48 — Never | 6 |
| Week 48 — Some of the time | 61 |
| Week 48 — All of the time | 194 |
| Week 48 — No special instructions | 389 |
| Week 96 — Never | 8 |
| Week 96 — Some of the time | 74 |
| Week 96 — All of the time | 190 |
| Week 96 — No special instructions | 365 |
Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.
| Participants | Continue HAART |
|---|---|
| Week 0 — No | 592 |
| Week 0 — Yes | 61 |
| Week 48 — No | 564 |
| Week 48 — Yes | 71 |
| Week 96 — No | 544 |
| Week 96 — Yes | 77 |
Quality of Life was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.
| Participants | Continue HAART | Stop HAART |
|---|---|---|
| week 0 — Excellent | 160 | 164 |
| week 0 — Very good | 262 | 269 |
| week 0 — Good | 327 | 333 |
| week 0 — Fair | 71 | 51 |
| week 0 — Poor | 3 | 1 |
| week 48 — Excellent | 172 | 185 |
| week 48 — Very good | 250 | 229 |
| week 48 — Good | 222 | 238 |
| week 48 — Fair | 52 | 48 |
| week 48 — Poor | 5 | 1 |
| week 96 — Excellent | 131 | 134 |
| week 96 — Very good | 179 | 178 |
| week 96 — Good | 165 | 157 |
| week 96 — Fair | 23 | 34 |
| week 96 — Poor | 2 | 1 |
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
| units on a scale | Continue HAART | Stop HAART |
|---|---|---|
| week 0 | 82.7 ± 15.7 | 83.0 ± 15.1 |
| week 48 | 85.3 ± 14.7 | 85.4 ± 14.0 |
| week 96 | 86.2 ± 14.1 | 86.3 ± 14.0 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over From study entry to off study date (an average of 125 weeks of follow-up).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Continue HAART | 2/827 (0.2%) | 10/827 (1.2%) | 778/827 (94.1%) |
| Stop HAART | 4/825 (0.5%) | 3/825 (0.4%) | 765/825 (92.7%) |
| Event | Continue HAART | Stop HAART |
|---|---|---|
| Abortion incompletePregnancy, puerperium and perinatal conditions | 2/827 | 0/825 |
| Foetal deathPregnancy, puerperium and perinatal conditions | 2/827 | 0/825 |
| StillbirthPregnancy, puerperium and perinatal conditions | 2/827 | 1/825 |
| EndophthalmitisInfections and infestations | 0/827 | 1/825 |
| Suicide attemptPsychiatric disorders | 0/827 | 1/825 |
| Pelvic inflammatory diseaseInfections and infestations | 1/827 | 0/825 |
| Ergot poisoningInjury, poisoning and procedural complications | 1/827 | 0/825 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/827 | 0/825 |
| Abortion inducedSurgical and medical procedures | 1/827 | 0/825 |
| Event | Continue HAART | Stop HAART |
|---|---|---|
| Blood cholesterol increasedInvestigations | 527/827 | 500/825 |
| Low density lipoprotein increasedInvestigations | 459/827 | 427/825 |
| PregnancyPregnancy, puerperium and perinatal conditions | 183/827 | 176/825 |
| Blood bilirubin increasedInvestigations | 148/827 | 57/825 |
| Blood glucose increasedInvestigations | 117/827 | 123/825 |
| Blood glucose decreasedInvestigations | 121/827 | 91/825 |
| Cervical dysplasiaReproductive system and breast disorders | 94/827 | 118/825 |
| Blood phosphorus decreasedInvestigations | 103/827 | 76/825 |
| Blood sodium decreasedInvestigations | 88/827 | 100/825 |
| Vulvovaginal candidiasisInfections and infestations | 58/827 | 97/825 |
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
| Age, Categorical(Participants) | Continue HAART | Stop HAART | Total |
|---|---|---|---|
| <=18 years | 18 | 18 | 36 |
| Between 18 and 65 years | 809 | 807 | 1616 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Continue HAART | Stop HAART | Total |
|---|---|---|---|
| Median | 27 (23 to 32) | 28 (24 to 32) | 28 (23 to 32) |
| Sex: Female, Male(Participants) | Continue HAART | Stop HAART | Total |
|---|---|---|---|
| Female | 827 | 825 | 1652 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Continue HAART | Stop HAART | Total |
|---|---|---|---|
| Haiti | 32 | 29 | 61 |
| Argentina | 20 | 25 | 45 |
| United States | 72 | 77 | 149 |
| Botswana | 230 | 227 | 457 |
| China | 52 | 52 | 104 |
| Brazil | 259 | 255 | 514 |
| Thailand | 156 | 151 | 307 |
| Peru | 6 | 9 | 15 |
| Race/Ethnicity(Participants) | Continue HAART | Stop HAART | Total |
|---|---|---|---|
| Asian | 209 | 203 | 412 |
| Black or African American | 58 | 58 | 116 |
| White | 123 | 127 | 250 |
| American Indian | 1 | 1 | 2 |
| Alaskan Native | 0 | 1 | 1 |
| Black African | 230 | 227 | 457 |
| Black of African origin | 77 | 70 | 147 |
| Mestizo | 6 | 8 | 14 |
| Mixed Black | 73 | 76 | 149 |
| Mixed native | 0 | 4 | 4 |
| Native (native Brazilian-Xavante/Kaigang/Guarani) | 1 | 1 | 2 |
| Other | 31 | 31 | 62 |
| Subject does not know | 4 | 2 | 6 |
| Race not available to clinic | 14 | 16 | 30 |
| Body Mass Index (BMI)(kg/m^2) | Continue HAART | Stop HAART | Total |
|---|---|---|---|
| Median | 24.4 (21.7 to 28.0) | 24.6 (21.8 to 28.3) | 24.5 (21.8 to 28.1) |
| WHO stage at entry(Participants) | Continue HAART | Stop HAART | Total |
|---|---|---|---|
| Clinical Stage I | 810 | 811 | 1621 |
| Clinical Stage II | 16 | 11 | 27 |
| Clinical Stage III | 1 | 1 | 2 |
| Duration of Antiretroviral therapy (ART) prior to study entry(weeks) | Continue HAART | Stop HAART | Total |
|---|---|---|---|
| Median | 17 (11 to 23) | 17 (11 to 23) | 17 (11 to 23) |
6 further baseline measures are reported on the registry.
Plan to share: No
Ran from Jan 2010 to primary completion in Aug 2016, 79 months.
Results were first posted in Feb 2018, 1 year 5 months after primary completion.
Of 78 non-industry phase 4 interventional studies under HIV Infections, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 45. This study's 79 months is above that.
Counting every sponsor, half of 90 studies reached it within 35 months; a quarter within 23 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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International Maternal Pediatric Adolescent AIDS Clinical Trials Group