A Phase 4 interventional study of Atripla (r) and Efavirenz in HIV Infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. Completed at 18 sites in 10 countries. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Phase 4, Interventional, and Treatment
People with HIV have a high chance of becoming infected with TB, especially when they live in areas where TB infection is common. It can be difficult to diagnose TB in people who need to start HIV treatment right away. Within about 6 months after starting HIV treatment, some of these people can become very sick with TB and can even die from it.
This study was being done in people who were starting HIV treatment and who lived in areas where the TB infection rate is high. The purpose of this study was to test an experimental approach to TB treatment to see if it is better than the usual approach. The experimental approach was to start TB treatment at the same time as HIV treatment, even when TB infection had not been found. The usual approach was to start TB treatment only if TB infection was found.
In this study, half of the people started TB treatment at the same time as they started their HIV treatment. The other half started TB treatment only if TB infection was found.
The study also tested how safe and effective it was to start TB treatment at about the same time as HIV treatment even when TB infection had not been found. The study collected information about diet, whether (and when) people in the study became sicker or died, how well their HIV was controlled, how they were feeling, how they were taking their medications, whether it mattered where they lived or what kind of HIV and TB care was standard, how many people were diagnosed with TB while in the study, and how the cost of the two treatment options on a national level could be compared.
This was a randomized, open-label, phase IV strategy trial for participants from resource-limited settings (RLS) who presented with advanced HIV disease and no probable or confirmed tuberculosis (TB), and who were initiating antiretroviral treatment (ART).
Participants were randomized to one of two strategy arms: immediate, empiric TB treatment (Empiric arm) or local standard of care TB treatment (IPT arm).
Randomization was balanced by clinical trial unit and stratified according to CD4+ T cell count (\<25 vs. ≥25 cells/mm\^3) and presence of any of the following prognostic factors: reportable hospitalization within the past 30 days, BMI \<18.5 kg/m\^2, or anemia (hemoglobin \<8 g/dl).
Participants were followed for 96 weeks. Participants attended study visits at screening, enrollment, and weeks 1, 2, 4, 8, 12, 16, 20, 24 and 48. Signs and symptoms, ART modifications, concomitant medications, and clinical events as defined by AIDS Clinical Trials Group (ACTG) Appendix 60 were collected at each visit. Blood was collected for CD4 and HIV-1 RNA at study entry, weeks 4, 24 and 48, and blood for safety laboratories (liver function, hematology, and renal function) was collected at all visits except week 1. A sputum sample was collected and stored at study entry. Phone contact was conducted at weeks 60, 72, 84 and 96 to obtain information about vital status, reportable hospitalization, TB status (including screening and follow-up), TB and HIV treatment modifications, and quality of life.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 851 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections is the lead sponsor of 70 studies on the registry; 3 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
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.
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.
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.
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.
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.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
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.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
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.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
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.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
Drug: Atripla (r) · Drug: Efavirenz · Drug: Truvada · Drug: Rifampin/isoniazid/pyrazinamide/ethambutol FDC · Drug: Rifampin/isoniazid FDC
Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
Drug: Atripla (r) · Drug: Efavirenz · Drug: Truvada · Drug: Isoniazid
Patients are administered one tablet of Efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (EFV/FTC/TDF, Atripla) to taken be taken orally once daily at bedtime without food.
Participants will take one 600 mg tablet administered orally once daily without food.
Also known as: EFV
Participants will take one tablet of Emtricitabine 200mg/tenofovir disoproxil fumarate 300mg (FTC/TDF, Truvada) administered orally once daily with or without food.
Drug pages: Rifampin · Isoniazid · Pyrazinamide · Ethambutol
Participants will be administered Rifampin/isoniazid/pyrazinamide/ethambutol FDC tablets orally, once daily; dose by weight as determined in Table 5.1-1 of the protocol, for the first 8 weeks.
Drug pages: Rifampin · Isoniazid
Participants will be administered rifampin/isoniazid FDC tablets orally, once daily; dose by weight as determined in Table 5.1-1 in the protocol, for 16 weeks following the first 8 weeks.
INH 300 mg orally once daily
Cumulative Probability of Death or Unknown Vital Status by Week 24
The Kaplan-Meier estimate of the cumulative probability of death or unknown vital status by week 24. The vital status was considered unknown at week 24 if a participant prematurely discontinued from the study before week 24 and no vital status was obtained at week 48.
Time frame: From study entry to week 24
Cumulative Probability of Death by Week 24
The Kaplan-Meier estimate of cumulative probability of death by week 24
Time frame: From study entry to week 24
Cumulative Probability of First AIDS Progression by Week 96
The Kaplan-Meier estimate of the cumulative probability of first AIDS progression which was defined as the identification of a new World Health Organization (WHO) stage 3 or 4 condition
Time frame: From study entry to week 96
Cumulative Probability of Death or AIDS Progression by Week 24
The Kaplan-Meier estimate of the cumulative probability of death or AIDS progression by week 24. AIDS progression was defined as new WHO stage 3 or 4 conditions occurred after study entry.
Time frame: From study entry to week 24
Proportion of Participants With HIV-1 RNA Level <400 Copies/mL
Proportion of participants with HIV-1 RNA level \<400 copies/mL.
Time frame: At weeks 0, 4, 24, and 48
CD4+ T-cell Count
The absolute levels of CD4+ T-cell counts (cells/mm\^3)
Time frame: At weeks 0, 4, 24, and 48
CD4+ T-cell Count Change From Baseline
Change was calculated as the CD4+ T-cell count at the later weeks (4, 24 and 48) minus the baseline (week 0) CD4+ T-cell count.
Time frame: Weeks 0, 4, 24 and 48
Time to Initiation of TB Treatment by Week 96
Median time to TB treatment initiation since study entry
Time frame: From study entry to week 96
Proportion of Participants With TB Diagnosis by Week 96
Proportion of participants with TB diagnosis per current ACTG Diagnosis Appendix 60 by week 96
Time frame: From study entry to week 96
Proportion of Participants With at Least One New Grade 3 or 4 Adverse Event That is at Least a One-grade Increase From Baseline by Week 48
Proportion of participants with at least one new Grade 3 or 4 laboratory or sign or symptom that is at least a one-grade increase from baseline by Week 48. Grade 3=Severe, Grade 4=Life-Threatening according to DAIDS AE Grading Table (see references).
Time frame: From study entry to week 48
Proportion of Participants With at Least One New Grade 3 or 4 Targeted Laboratory Value That is at Least a One-grade Increase From Baseline by Week 48
Proportion of participants with at least one new Grade 3 or 4 that is at least a one-grade increase from baseline for the following targeted laboratory values by Week 48 The targeted laboratory events include hemoglobin, serum creatinine, ALT and AST
Time frame: From study entry to week 48. The lab events were collected at study entry, weeks 2, 4, 8, 12, 16, 20, 24, and 48.
Proportion of Participants With Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48
Proportion of participants with IRIS (using current ACTG definition Appendix 60, see References) by Week 48. IRIS in participants with TB and other opportunistic infections may occur shortly after the initiation of potent combination ART, particularly in participants with advanced HIV disease.
Time frame: From study entry to week 48
Proportion of Participants With Reportable Hospitalization by Week 48
Proportion of participants with reportable hospitalization reported by Week 48
Time frame: From study entry to week 48
Proportion of Participants Who Prematurely Discontinued Any Component of TB Treatment by Week 48
Proportion of participants with premature discontinuation of any component of TB treatment by Week 48
Time frame: From study entry to week 48
Proportion of Participants Who Prematurely Discontinued Antiretroviral Therapy by Week 48
Proportion of participants with premature discontinuation of antiretroviral therapy (ART) by Week 48
Time frame: From study entry to week 48
Cumulative Probability of Death or AIDS Progression by Week 48
The Kaplan-Meier estimate of the cumulative probability of death or AIDS progression by week 48. AIDS progression was defined as new WHO stage 3 or 4 conditions occurred after study entry.
Time frame: From study entry to week 48
Recruited at AIDS Clinical Trials Units in 10 international countries. Recruitment occurred between October 31, 2011 (date of first participant was randomized) and June 9, 2014 (date of last participant was randomized).
| Milestone | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Started | 424 | 426 |
| Completed | 339 | 343 |
| Not completed | 85 | 83 |
| Withdrew: Death | 36 | 44 |
| Withdrew: Site is closing | 28 | 31 |
| Withdrew: Not able to get to clinic | 7 | 1 |
| Withdrew: Not willing to adhere to requirements | 6 | 2 |
| Withdrew: Withdrawal by subject | 5 | 2 |
| Withdrew: Lost to follow-up | 3 | 3 |
The Kaplan-Meier estimate of the cumulative probability of death or unknown vital status by week 24. The vital status was considered unknown at week 24 if a participant prematurely discontinued from the study before week 24 and no vital status was obtained at week 48.
| Cumulative probability per 100 persons | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Cumulative Probability of Death or Unknown Vital Status by Week 24 | 5.2 (3.5 to 7.8) | 5.2 (3.4 to 7.8) |
The Kaplan-Meier estimate of cumulative probability of death by week 24
| Cumulative probability per 100 persons | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Cumulative Probability of Death by Week 24 | 4.8 (3.1 to 7.3) | 5.2 (3.4 to 7.8) |
The Kaplan-Meier estimate of the cumulative probability of first AIDS progression which was defined as the identification of a new World Health Organization (WHO) stage 3 or 4 condition
| Cumulative probability per 100 persons | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Cumulative Probability of First AIDS Progression by Week 96 | 16.6 (13.3 to 20.6) | 11.3 (8.6 to 14.8) |
The Kaplan-Meier estimate of the cumulative probability of death or AIDS progression by week 24. AIDS progression was defined as new WHO stage 3 or 4 conditions occurred after study entry.
| Cumulative probability per 100 persons | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Cumulative Probability of Death or AIDS Progression by Week 24 | 17.1 (13.9 to 21.1) | 12.5 (9.7 to 16.0) |
Proportion of participants with HIV-1 RNA level \<400 copies/mL.
| Proportion of participants | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Week 0 | 0 (0 to 0.02) | 0.01 (0 to 0.03) |
| Week 4 | 0.46 (0.41 to 0.51) | 0.49 (0.44 to 0.55) |
| Week 24 | 0.84 (0.79 to 0.87) | 0.85 (0.81 to 0.89) |
| Week 48 | 0.87 (0.83 to 0.90) | 0.89 (0.86 to 0.92) |
The absolute levels of CD4+ T-cell counts (cells/mm\^3)
| cells/ mm^3 | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Week 0 | 18 (9 to 31) | 19 (9 to 33) |
| Week 4 | 74 (37 to 118) | 76 (41 to 123) |
| Week 24 | 121 (75 to 172) | 121 (80 to 188) |
| Week 48 | 176 (112 to 251) | 172 (112 to 245) |
Change was calculated as the CD4+ T-cell count at the later weeks (4, 24 and 48) minus the baseline (week 0) CD4+ T-cell count.
| cells/ mm^3 | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Week 4 | 49 (20 to 91) | 54 (22 to 94) |
| Week 24 | 96 (55 to 147) | 102 (60 to 159) |
| Week 48 | 158 (92 to 224) | 146 (90 to 219) |
Median time to TB treatment initiation since study entry
| Days | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Time to Initiation of TB Treatment by Week 96 | 0 (0 to 1) | 0 (0 to 1) |
Proportion of participants with TB diagnosis per current ACTG Diagnosis Appendix 60 by week 96
| Proportion of participants | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Proportion of Participants With TB Diagnosis by Week 96 | 0.08 | 0.05 |
Proportion of participants with at least one new Grade 3 or 4 laboratory or sign or symptom that is at least a one-grade increase from baseline by Week 48. Grade 3=Severe, Grade 4=Life-Threatening according to DAIDS AE Grading Table (see references).
| Proportion of participants | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Proportion of Participants With at Least One New Grade 3 or 4 Adverse Event That is at Least a One-grade Increase From Baseline by Week 48 | 0.32 | 0.30 |
Proportion of participants with at least one new Grade 3 or 4 that is at least a one-grade increase from baseline for the following targeted laboratory values by Week 48 The targeted laboratory events include hemoglobin, serum creatinine, ALT and AST
| Proportion of participants | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Proportion of Participants With at Least One New Grade 3 or 4 Targeted Laboratory Value That is at Least a One-grade Increase From Baseline by Week 48 | 0.11 | 0.13 |
Proportion of participants with IRIS (using current ACTG definition Appendix 60, see References) by Week 48. IRIS in participants with TB and other opportunistic infections may occur shortly after the initiation of potent combination ART, particularly in participants with advanced HIV disease.
| Proportion of participants | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Proportion of Participants With Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 | 0.04 | 0.05 |
Proportion of participants with reportable hospitalization reported by Week 48
| Proportion of participants | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Proportion of Participants With Reportable Hospitalization by Week 48 | 0.10 | 0.12 |
Proportion of participants with premature discontinuation of any component of TB treatment by Week 48
| Proportion of participants | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Proportion of Participants Who Prematurely Discontinued Any Component of TB Treatment by Week 48 | 0.13 | 0.05 |
Proportion of participants with premature discontinuation of antiretroviral therapy (ART) by Week 48
| Proportion of participants | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Proportion of Participants Who Prematurely Discontinued Antiretroviral Therapy by Week 48 | 0.19 | 0.21 |
The Kaplan-Meier estimate of the cumulative probability of death or AIDS progression by week 48. AIDS progression was defined as new WHO stage 3 or 4 conditions occurred after study entry.
| Cumulative probability per 100 persons | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Cumulative Probability of Death or AIDS Progression by Week 48 | 19.3 (15.8 to 23.4) | 15.3 (12.2 to 19.1) |
Collected over From treatment dispensation to up to week 96. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: Empiric | 36/424 (8.5%) | 85/424 (20%) | 380/424 (89.6%) |
| Arm B: IPT | 44/426 (10.3%) | 94/426 (22.1%) | 379/426 (89%) |
| Event | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Meningitis cryptococcalInfections and infestations | 6/424 | 9/426 |
| DeathGeneral disorders | 2/424 | 8/426 |
| AnaemiaBlood and lymphatic system disorders | 7/424 | 7/426 |
| DiarrhoeaGastrointestinal disorders | 7/424 | 1/426 |
| PneumoniaInfections and infestations | 7/424 | 3/426 |
| GastroenteritisInfections and infestations | 6/424 | 6/426 |
| Pneumonia bacterialInfections and infestations | 5/424 | 3/426 |
| DehydrationMetabolism and nutrition disorders | 5/424 | 1/426 |
| Meningitis tuberculousInfections and infestations | 1/424 | 5/426 |
| Drug-induced liver injuryHepatobiliary disorders | 4/424 | 3/426 |
| Event | Arm A: Empiric | Arm B: IPT |
|---|---|---|
| Neutrophil count decreasedInvestigations | 161/424 | 163/426 |
| Blood albumin decreasedInvestigations | 151/424 | 159/426 |
| Blood sodium decreasedInvestigations | 144/424 | 140/426 |
| White blood cell count decreasedInvestigations | 136/424 | 130/426 |
| Haemoglobin decreasedInvestigations | 119/424 | 95/426 |
| Aspartate aminotransferase increasedInvestigations | 99/424 | 101/426 |
| Alanine aminotransferase increasedInvestigations | 58/424 | 75/426 |
| Blood bicarbonate decreasedInvestigations | 66/424 | 72/426 |
| PyrexiaGeneral disorders | 46/424 | 55/426 |
| VomitingGastrointestinal disorders | 39/424 | 51/426 |
Intent to treat: All eligible participants were included in the baseline characteristics.
| Age, Continuous(years) | Arm A: Empiric | Arm B: IPT | Total |
|---|---|---|---|
| Median | 36 (30 to 42) | 35 (30 to 42) | 36 (30 to 42) |
| Sex: Female, Male(Participants) | Arm A: Empiric | Arm B: IPT | Total |
|---|---|---|---|
| Female | 200 | 200 | 400 |
| Male | 224 | 226 | 450 |
| Race/Ethnicity, Customized(Participants) | Arm A: Empiric | Arm B: IPT | Total |
|---|---|---|---|
| Black Non-Hispanic | 375 | 384 | 759 |
| Hispanic (Regardless of Race) | 32 | 29 | 61 |
| Asian, Pacific Islander | 17 | 13 | 30 |
| Region of Enrollment(Participants) | Arm A: Empiric | Arm B: IPT | Total |
|---|---|---|---|
| Haiti | 53 | 56 | 109 |
| Malawi | 95 | 98 | 193 |
| Brazil | 9 | 6 | 15 |
| South Africa | 86 | 90 | 176 |
| Zimbabwe | 25 | 27 | 52 |
| Uganda | 25 | 24 | 49 |
| Zambia | 17 | 19 | 36 |
| Kenya | 77 | 75 | 152 |
| Peru | 20 | 19 | 39 |
| India | 17 | 12 | 29 |
| HIV-1 RNA(log10 copies/mL) | Arm A: Empiric | Arm B: IPT | Total |
|---|---|---|---|
| Median | 5.4 (5.0 to 5.7) | 5.3 (4.9 to 5.7) | 5.3 (4.9 to 5.7) |
| CD4+ T-cell count(cells/mm^3) | Arm A: Empiric | Arm B: IPT | Total |
|---|---|---|---|
| Median | 18 (9 to 31) | 19 (9 to 33) | 18 (9 to 32) |
Ran from Oct 2011 to primary completion in Jan 2015, 39 months.
Results were first posted in Feb 2016, 1 year 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 39 months is close to 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 Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Rifampin · Isoniazid · Pyrazinamide · Ethambutol
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections