Trial · NCT00099359
Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission
NCT00099359, Phase 3, Completed, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); results first posted 2012-12-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission. Trials, record NCT00099359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00099359
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission
- NCT number
- NCT00099359
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,735 participants, actual
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Conditions
- Disease Transmission, Vertical, Vertical Human Immunodeficiency Virus Transmission, HIV Infections
- Interventions
- Zidovudine, Nevirapine (NVP), Epivir (3TC), Nelfinavir (NFV)
- First posted
- 2004-12-13
- Last updated
- 2012-12-04
- Results first posted
- 2012-12-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Infant HIV Infection Status | 3 months | Intrapartum HIV infection at 3 Months |
| Primary | Participants With Serious Adverse Events | through age 6 months. | Serious Adverse Events by System Organ Class=Blood and lymphatic system disorders |
| Secondary | Infant HIV-1 Infection Status | birth | In utero HIV-1 infection rate |
| Secondary | Participant Deaths | through age 6 months | |
| Secondary | Clinical Covariates of HIV-1 Infection | through age 3 months | Compare HIV-1 RNA levels; CD4+ lymphocyte counts; and rates of genotypic and phenotypic resistance among the three treatment regimens. |
| Secondary | 3TC and NFV Pharmacokinetics | through age 14 days | Descriptive study of 3TC and NFV pharmacokinetics during first two weeks of life using weight band dosing regimen in a subset of enrolled infants. |
| Secondary | Risk Factors for Perinatal HIV-1 Transmission | through age 3 months | Risk factors to be assessed include maternal HIV-1 RNA levels at delivery, maternal syphilis and other infections, obstetrical factors such as duration of membrane rupture, and adherence to neonatal medication. |
| Secondary | NVP Pharmacokinetics | 14 days | Descriptive study of NVP pharmacokinetics during first two weeks of life using weight band dosing in a subset of enrolled infants. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Infant HIV Infection Status | 3 months | All infants with HIV-1 test results except infants infected at birth (i.e. in utero infections) were included in these analysis. | participants | NUMBER |
| PRIMARY | Participants With Serious Adverse Events | through age 6 months. | participants | NUMBER | |
| SECONDARY | Infant HIV-1 Infection Status | birth | participants | NUMBER | |
| SECONDARY | Participant Deaths | through age 6 months | participants | NUMBER | |
| SECONDARY | Clinical Covariates of HIV-1 Infection | through age 3 months | |||
| SECONDARY | 3TC and NFV Pharmacokinetics | through age 14 days | This was a descriptive study. A total of 26 infants were analyzed with 14 at age 4-7 days and 12 at 10-14 days.Plasma samples were collected prior to first AM dose and then at 1,2,4,8 and 12 hours. | ug*h/mL | MEDIAN |
| SECONDARY | Risk Factors for Perinatal HIV-1 Transmission | through age 3 months | All available demographic and clinical variables were tested for association with transmission rate. All variables that were significant at p ≤ 0.20 were included in the multivariable regression model. Variables that were not significant were then removed from the model. The backward elimination method was used to select the final model. | participants | NUMBER |
| SECONDARY | NVP Pharmacokinetics | 14 days | ng/mL | MEDIAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Infant HIV Infection Status | ARM A (ZDV - Standard of Care) | 24 | participants | ||
| Infant HIV Infection Status | ARM B (ZDV + NVP) | 11 | participants | ||
| Infant HIV Infection Status | ARM C (ZDV +3TC+NFV) | 12 | participants | ||
| Participants With Serious Adverse Events | ARM A (ZDV Only) | 86 | participants | ||
| Participants With Serious Adverse Events | ARM B (ZDV + NVP) | 59 | participants | ||
| Participants With Serious Adverse Events | ARM C (ZDV + 3TC/NFV) | 110 | participants | ||
| Infant HIV-1 Infection Status | Arm A (ZDV Only) | 37 | participants | ||
| Infant HIV-1 Infection Status | ARM B (ZDV + NVP) | 28 | participants | ||
| Infant HIV-1 Infection Status | ARM C (ZDV + 3TC + NFV) | 28 | participants | ||
| Participant Deaths | Arm A (ZDV Only) | 11 | participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (ZDV Only) | 581 | |
| Overall Study | STARTED | ARM B (ZDV + NVP) | 580 | |
| Overall Study | STARTED | ARM C (ZDV + 3TC + NFV) | 574 | |
| Overall Study | COMPLETED | Arm A (ZDV Only) | 527 | |
| Overall Study | COMPLETED | ARM B (ZDV + NVP) | 515 | |
| Overall Study | COMPLETED | ARM C (ZDV + 3TC + NFV) | 506 | |
| Overall Study | NOT COMPLETED | Arm A (ZDV Only) | 54 | |
| Overall Study | NOT COMPLETED | ARM B (ZDV + NVP) | 65 | |
| Overall Study | NOT COMPLETED | ARM C (ZDV + 3TC + NFV) | 68 |
Source ClinicalTrials.gov
Adverse events486
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia NOS | Blood and lymphatic system disorders | ARM A (ZDV Alone) | 286 | 581 | 451 |
| other | Anaemia NOS | Blood and lymphatic system disorders | ARM B (ZDV + NVP) | 270 | 580 | 402 |
| other | Anaemia NOS | Blood and lymphatic system disorders | ARM C (ZDV + 3TC/NFV) | 287 | 574 | 456 |
| other | neutropenia | Blood and lymphatic system disorders | ARM A (ZDV Alone) | 225 | 581 | 294 |
| other | neutropenia | Blood and lymphatic system disorders | ARM B (ZDV + NVP) | 119 | 580 | 261 |
| other | neutropenia | Blood and lymphatic system disorders | ARM C (ZDV + 3TC/NFV) | 244 | 574 | 334 |
| other | oral candidiasis | Infections and infestations | ARM A (ZDV Alone) | 162 | 581 | 188 |
| other | oral candidiasis | Infections and infestations | ARM B (ZDV + NVP) | 170 | 580 | 194 |
| other | oral candidiasis | Infections and infestations | ARM C (ZDV + 3TC/NFV) | 156 | 574 | 177 |
| other | Aspartate Aminotransferase Increased | Investigations | ARM A (ZDV Alone) | 335 | 581 | 439 |
1 to 10 of 486Source ClinicalTrials.gov
See all 486 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ARM A (ZDV Alone) | ||
| Total, all-cause mortality | ARM B (ZDV + NVP) | ||
| Total, all-cause mortality | ARM C (ZDV + 3TC/NFV) | ||
| Total, other adverse events | ARM A (ZDV Alone) | 492 | 581 |
| Total, other adverse events | ARM B (ZDV + NVP) | 482 | 580 |
| Total, other adverse events | ARM C (ZDV + 3TC/NFV) | 480 | 574 |
| Total, serious adverse events | ARM A (ZDV Alone) | 219 | 581 |
| Total, serious adverse events | ARM B (ZDV + NVP) | 211 | 580 |
| Total, serious adverse events | ARM C (ZDV + 3TC/NFV) | 252 | 574 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
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.
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/NCT00099359
GET https://conductscience.org/api/trials/v1/NCT00099359/results?page=2