Trial · NCT00307151
Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV
NCT00307151, Phase 2, Completed, International Maternal Pediatric Adolescent AIDS Clinical Trials Group; results first posted 2011-08-03
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ConductScience Library. Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV. Trials, record NCT00307151. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00307151
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV
- NCT number
- NCT00307151
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 452 participants, actual
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Conditions
- HIV Infections
- Interventions
- Lamivudine, Lopinavir/ritonavir, Nevirapine, Zidovudine
- First posted
- 2006-03-27
- Last updated
- 2017-04-13
- Results first posted
- 2011-08-03
- Limitations and caveats
- Accrual to Cohort I was terminated early by the Data Safety Monitoring Committee after enrollment of 164 of the planned 288 subjects.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment | Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010) | Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is \<1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level \>400 copies/mL at 24 weeks OR permanent discontinuation of the randomized NNRTI or PI component of study treatment at or prior to 24 weeks of treatment for any reason including death. Results report percent of participants reaching a treatment failure endpoint by week 24 calculated using the Kaplan-Meier method. |
| Secondary | Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment | Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks) | Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is \<1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level \>400 copies/mL at 24 weeks OR a confirmed viral rebound \>4000 copies/mL after week 24 OR permanent discontinuation of the randomized NNRTI or PI component of study treatment for any reason including death. |
| Secondary | Percent of Participants Experiencing Virologic Failure | Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010) | Virologic failure is defined as a confirmed plasma HIV-1 RNA level that is \<1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level \>400 copies/mL at 24 weeks OR death on or before 24 weeks. Results report percent of participants reaching a virologic failure endpoint by week 24 calculated using the Kaplan-Meier method. |
| Secondary | Time From Randomization to Virologic Failure | Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks) | Virologic failure is defined as the earlier of a confirmed plasma HIV-1 RNA level that is \<1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level \>400 copies/mL at 24 weeks OR a confirmed viral rebound \>4000 copies/mL after week 24 OR death. |
| Secondary | Time From Start of Study Treatment to First New Grade >=3 Lab Abnormality, Sign or Symptom Occurring on Study Treatment | On randomized NNRTI or PI component of study treatment and until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010) | Safety events include lab abnormalities, signs or symptoms of grade 3 or higher. Events were graded according to the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events, Version 1.0. Events defined as new if first occurrence was after initiation of study treatment or if severity increased from entry and while on the NNRTI or PI component of study treatment. |
| Secondary | Number of Participants Developing New NRTI, NNRTI or PI-resistant Virus | Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks) | Numbers of participants developing new NRTI, NNRTI or PI-resistant virus after reaching a virologic failure endpoint |
| Secondary | Change in CD4 Percent From Entry to Week 48 | 48 weeks if before date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010) | Change was calculated as CD4 percent at week 48 minus entry CD4 percent (last CD4 percent before randomization date). Only subjects who reached 48 weeks of follow-up before DSMB decisions to unblind each Cohort were included in summary. |
| Secondary | Time From Randomization to HIV-related Disease Progression or Death | Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks) | HIV-related disease progression was defined as progression in WHO clinical stage from stage at entry or death. For subjects in WHO Stage IV at entry, disease progression was defined as death. |
| Secondary | Time From Randomization to Death | Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks) | Results report 2nd percentile of time from randomization to death |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment | Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010) | Analysis uses intent to treat population | Percent of participants | NUMBER |
| SECONDARY | Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment | Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks) | Analysis uses intent to treat population | Weeks | NUMBER |
| SECONDARY | Percent of Participants Experiencing Virologic Failure | Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010) | Analysis uses intent to treat population. | Percent of participants | NUMBER |
| SECONDARY | Time From Randomization to Virologic Failure | Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks) | Analysis uses intent to treat population | Weeks | NUMBER |
| SECONDARY | Time From Start of Study Treatment to First New Grade >=3 Lab Abnormality, Sign or Symptom Occurring on Study Treatment | On randomized NNRTI or PI component of study treatment and until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010) | Uses follow-up from start of NVP or LPV/r component of study treatment until component switched or date of DSMB decision to unblind results, whichever occurred first | Weeks | NUMBER |
| SECONDARY | Number of Participants Developing New NRTI, NNRTI or PI-resistant Virus | Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks) | Results included for any participant who was a virologic failure as defined in secondary outcome 4 and who had results available at study entry and virologic failure. | participants | NUMBER |
| SECONDARY | Change in CD4 Percent From Entry to Week 48 | 48 weeks if before date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010) | Analysis uses intent to treat population. Change reported if subject followed at least 48 weeks before DSMB unblinding of results for each Cohort | Percent of CD4 | MEAN |
| SECONDARY | Time From Randomization to HIV-related Disease Progression or Death | Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks) | Analysis uses intent to treat population | Weeks | NUMBER |
| SECONDARY | Time From Randomization to Death | Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks) | Analysis uses intent to treat population | Weeks | NUMBER |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment | Coh I: NVP | 39.6 | Percent of participants | ||
| Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment | Coh I: LPV/r | 21.7 | Percent of participants | ||
| Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment | Coh II: NVP | 40.8 | Percent of participants | ||
| Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment | Coh II: LPV/r | 19.3 | Percent of participants | ||
| Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment | Coh I: NVP | 10th percentile | 12 | 95% Confidence Interval 4 to 12 | Weeks |
| Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment | Coh I: LPV/r | 10th percentile | 4 | 95% Confidence Interval 4 to 16 | Weeks |
| Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment | Coh II: NVP | 10th percentile | 4 | 95% Confidence Interval 2 to 8 | Weeks |
| Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment | Coh II: LPV/r | 10th percentile | 14 | 95% Confidence Interval 8 to 24 | Weeks |
| Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment | Coh I: NVP | 25th percentile | 16 | 95% Confidence Interval 12 to 24 | Weeks |
| Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment | Coh I: LPV/r | 25th percentile | 36 | 95% Confidence Interval 16 to NA | Weeks |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Coh I: NVP | 82 | |
| Overall Study | STARTED | Coh I: LPV/r | 82 | |
| Overall Study | STARTED | Coh II: NVP | 147 | |
| Overall Study | STARTED | Coh II: LPV/r | 140 | |
| Overall Study | COMPLETED | Coh I: NVP | 71 | |
| Overall Study | COMPLETED | Coh I: LPV/r | 75 | |
| Overall Study | COMPLETED | Coh II: NVP | 127 | |
| Overall Study | COMPLETED | Coh II: LPV/r | 129 | |
| Overall Study | NOT COMPLETED | Coh I: NVP | 11 | |
| Overall Study | NOT COMPLETED | Coh I: LPV/r | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events464
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 | Blood and lymphatic system disorders | Coh I: NVP | 0 | 82 | |
| other | Anaemia | Blood and lymphatic system disorders | Coh I: LPV/r | 1 | 82 | |
| other | Anaemia | Blood and lymphatic system disorders | Coh II: NVP | 9 | 147 | |
| other | Anaemia | Blood and lymphatic system disorders | Coh II: LPV/r | 1 | 140 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Coh I: NVP | 1 | 82 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Coh I: LPV/r | 3 | 82 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Coh II: NVP | 17 | 147 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Coh II: LPV/r | 13 | 140 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Coh I: NVP | 2 | 82 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Coh I: LPV/r | 2 | 82 |
1 to 10 of 464Source ClinicalTrials.gov
See all 464 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Coh I: NVP | 6 | 82 |
| Total, all-cause mortality | Coh I: LPV/r | 3 | 82 |
| Total, all-cause mortality | Coh II: NVP | 10 | 147 |
| Total, all-cause mortality | Coh II: LPV/r | 6 | 140 |
| Total, other adverse events | Coh I: NVP | 81 | 82 |
| Total, other adverse events | Coh I: LPV/r | 82 | 82 |
| Total, other adverse events | Coh II: NVP | 146 | 147 |
| Total, other adverse events | Coh II: LPV/r | 140 | 140 |
| Total, serious adverse events | Coh I: NVP | 23 | 82 |
| Total, serious adverse events | Coh I: LPV/r | 19 | 82 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers11
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AI068632 | International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group | JACKSON, J BROOKS | SOCIAL AND SCIENTIFIC SYSTEMS, INC. | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2006 to 2010 |
Source NIH RePORTER
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/NCT00307151
GET https://conductscience.org/api/trials/v1/NCT00307151/results?page=2