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Trial · NCT00042289

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

NCT00042289, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2022-07-22

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy. Trials, record NCT00042289. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00042289

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
NCT number
NCT00042289
Status
Completed
Enrollment
1,578 participants, actual
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions
HIV Infections
Interventions
atazanavir/cobicistat, darunavir/ritonavir dosage #1, darunavir/ritonavir dosage #2, darunavir/ritonavir dosage #3, elvitegravir/cobicistat, dolutegravir, tenofovir alafenamide fumarate (TAF), TAF w/cobicistat, TAF w/cobicistat or ritonavir, efavirenz, darunavir/cobicistat, lopinavir/ritonavir dosage #1, atazanavir/ritonavir/tenofovir dosage #1, rifampicin, ethambutol, isoniazid, pyrazinamide, kanamycin, amikacin, capreomycin, moxifloxacin, levoflaxacin, ofloxacin, ethionamide/prothionamide, terizidone/cycloserine, para-aminosalicylic acid (PAS), high dose INH, bedaquiline, clofazamine, delamanid, linezolid, pretomanid, ethinyl estradiol, etonogestrel implant, nevirapine, amprenavir, abacavir, lopinavir/ritonavir dosage #2, indinavir/ritonavir dosage #1, fosamprenavir/ritonavir, lopinavir/ritonavir dosage #3, atazanavir/ritonavir dosage #1, didanosine delayed release (Videx® EC), emtricitabine, tenofovir, nelfinavir dosage #1, tipranavir/ritonavir, lopinavir/ritonavir dosage #4, raltegravir, etravirine, maraviroc, atazanavir/ritonavir dosage #2, tenofovir/atazanavir/ritonavir dosage #2, nelfinavir dosage #2, indinavir/ritonavir dosage #2, rilpivirine, darunavir/ritonavir dosage #4
First posted
2002-08-01
Last updated
2025-12-02
Results first posted
2022-07-22
Limitations and caveats
Over the course of the study, some study arms were discontinued or closed for reasons such as there being sufficient pharmacokinetic data from other studies or lack of enrollment (as specified in Protocol Section 8.42), leading to a low number of participants in those arms. In addition, due to the COVID-19 pandemic there was a delay in running assays for certain arms and/or analyzing PK results; the results for those arms will be reported when available.

Source ClinicalTrials.gov

Registered outcomes43

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs
Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule.
PrimaryPK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs
Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule.
PrimaryPK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs
Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
PrimaryPK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24 (area under the curve from 0 to 24 hours) were determined using the linear trapezoidal rule.
PrimaryPK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the trapezoidal rule.
PrimaryPK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.
PrimaryPK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.
PrimaryPK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.
PrimaryPK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.
PrimaryPK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs
Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose.

Outcomes43

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs
Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.
mg*hour/LMEDIAN
PRIMARYPK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs
Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.
mg*hour/LMEDIAN
PRIMARYPK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs
Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.
ng*hour/mLGEOMETRIC_MEAN
PRIMARYPK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.
All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.
mg*hour/LMEDIAN
PRIMARYPK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.
All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period. No 2nd trimester data were available for the EFV 600mg q.d. arm.
mg*hour/LMEDIAN
PRIMARYPK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.
mg/LMEDIAN
PRIMARYPK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.
mg/LMEDIAN
PRIMARYPK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.
ng/mLMEDIAN
PRIMARYPK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.
ng/mLMEDIAN
PRIMARYPK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs
Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.
All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.
mg/LMEDIAN

Results by group368

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB DrugsDRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.2nd Trimester55.1Inter-Quartile Range 46.4 to 57.7mg*hour/L
PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB DrugsFPV/RTV 700/100mg b.i.d.2nd Trimester43.50Inter-Quartile Range 38.50 to 50.40mg*hour/L
PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB DrugsDRV/RTV 600/100mg b.i.d.2nd Trimester45.8Inter-Quartile Range 36.1 to 53.4mg*hour/L
PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB DrugsNFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.2nd TrimesterNAInter-Quartile Range NA to NAmg*hour/L
PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB DrugsDRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.3rd Trimester51.8Inter-Quartile Range 41.2 to 57.7mg*hour/L
PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB DrugsFPV/RTV 700/100mg b.i.d.3rd Trimester32.15Inter-Quartile Range 21.45 to 39.70mg*hour/L
PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB DrugsDRV/RTV 600/100mg b.i.d.3rd Trimester45.9Inter-Quartile Range 29.3 to 52.5mg*hour/L
PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB DrugsNFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.3rd Trimester34.2Inter-Quartile Range 27.2 to 46.9mg*hour/L
PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB DrugsDRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.Postpartum79.6Inter-Quartile Range 66.6 to 103.0mg*hour/L
PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB DrugsFPV/RTV 700/100mg b.i.d.Postpartum51.60Inter-Quartile Range 45.20 to 59.60mg*hour/L

Participant flow235

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDDRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.26
Overall StudySTARTEDDTG 50mg q.d.30
Overall StudySTARTEDTAF 25mg q.d.27
Overall StudySTARTEDTAF 10mg q.d. w/COBI33
Overall StudySTARTEDTAF 25mg q.d. w/COBI or RTV Boosting29
Overall StudySTARTEDEVG/COBI 150/150mg q.d.31
Overall StudySTARTEDDRV/COBI 800/150 mg q.d.28
Overall StudySTARTEDATV/COBI 300/150 mg q.d.12
Overall StudySTARTEDEFV 600 mg q.d. (Outside THA)27
Overall StudySTARTEDEFV 600mg q.d. and at Least One 1st Line TB Drug24

Adverse events30,825

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAnaemiaBlood and lymphatic system disordersABC 300mg b.i.d. MOTHER026
otherAnaemiaBlood and lymphatic system disordersATV/COBI 300/150 mg q.d. INFANT012
otherAnaemiaBlood and lymphatic system disordersATV/COBI 300/150 mg q.d. MOTHER012
otherAnaemiaBlood and lymphatic system disordersATV/RTV 300/100mg q.d. INFANT022
otherAnaemiaBlood and lymphatic system disordersATV/RTV 300/100mg q.d. MOTHER022
otherAnaemiaBlood and lymphatic system disordersATV/RTV 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. INFANT038
otherAnaemiaBlood and lymphatic system disordersATV/RTV 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. MOTHER038
otherAnaemiaBlood and lymphatic system disordersATV/RTV/TFV 300/100/300mg q.d. With 30-35ug EE MOTHER028
otherAnaemiaBlood and lymphatic system disordersATV/RTV/TFV 300/100/300mg q.d. With ENG MOTHER025
otherAnaemiaBlood and lymphatic system disordersAt Least Two 2nd Line TB Drugs w/ or w/Out ARVs INFANT014

Adverse event totals225

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityABC 300mg b.i.d. MOTHER026
Total, all-cause mortalityATV/COBI 300/150 mg q.d. INFANT012
Total, all-cause mortalityATV/COBI 300/150 mg q.d. MOTHER012
Total, all-cause mortalityATV/RTV 300/100mg q.d. INFANT022
Total, all-cause mortalityATV/RTV 300/100mg q.d. MOTHER022
Total, all-cause mortalityATV/RTV 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. INFANT038
Total, all-cause mortalityATV/RTV 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. MOTHER038
Total, all-cause mortalityATV/RTV/TFV 300/100/300mg q.d. With 30-35ug EE MOTHER028
Total, all-cause mortalityATV/RTV/TFV 300/100/300mg q.d. With ENG MOTHER025
Total, all-cause mortalityAt Least Two 2nd Line TB Drugs w/ or w/Out ARVs INFANT014

Papers40

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
14562860BACKGROUNDPubMed
14977385BACKGROUNDPubMed
15228149BACKGROUNDPubMed
15568888BACKGROUNDPubMed
16470119RESULTPubMed
16988514RESULTPubMed
18366444RESULTPubMed
18795962RESULTPubMed
18989231RESULTPubMed
20002783RESULTPubMed

1 to 10 of 40

See all 40 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00042289

GET https://conductscience.org/api/trials/v1/NCT00042289/registered?page=2