Trial · NCT00099632
Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy
NCT00099632, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2012-01-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy. Trials, record NCT00099632. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00099632
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy
- NCT number
- NCT00099632
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 484 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV Infections
- Interventions
- Emtricitabine/Tenofovir Disoproxil Fumarate, Lamivudine/Zidovudine, Lopinavir/Ritonavir, single dose Nevirapine
- First posted
- 2004-12-20
- Last updated
- 2021-11-04
- Results first posted
- 2012-01-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping | 2 and 6 weeks after completion of treatment | For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed to the primary endpoint; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed to primary endpoint. 10 participants who did not have resistance samples available were excluded from the primary endpoint analysis. |
| Secondary | Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping. | 2 and 6 weeks after completion of treatment | For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed. |
| Secondary | Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping. | 2 and 6 weeks after completion of treatment | For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed. |
| Secondary | Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12 | From first day of study treatment to week 12 | Grade 3 or higher signs and symptoms, laboratory abnormalities, events that are reported through the EAE system, and any grade event that leads to a treatment change from first day of study treatment to week 12. Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death |
| Secondary | Number of Participants Who Discontinued Study Treatment Prematurely | From first day of study treatment to last day of study treatment (up to 21 days) | participants assigned to 7-day treatment arm and 21-day treatment arm were supposed to stay in study treatment for 7 days and 21 days respectively. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping | 2 and 6 weeks after completion of treatment | 412 women with primary endpoint results available | participants | NUMBER |
| SECONDARY | Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping. | 2 and 6 weeks after completion of treatment | participants | NUMBER | |
| SECONDARY | Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping. | 2 and 6 weeks after completion of treatment | participants | NUMBER | |
| SECONDARY | Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12 | From first day of study treatment to week 12 | participants | NUMBER | |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Prematurely | From first day of study treatment to last day of study treatment (up to 21 days) | participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 1 | participants | ||
| Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 0 | participants | ||
| Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0 | participants | ||
| Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0 | participants | ||
| Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping | 7-day Lopinavir/Ritonavir (LPV/r) | 3 | participants | ||
| Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping | 21-day Lopinavir/Ritonavir (LPV/r) | 1 | participants | ||
| Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping. | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 0 | participants | ||
| Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping. | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 1 | participants | ||
| Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping. | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 1 | participants | ||
| Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping. | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 1 | participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 73 | |
| Overall Study | STARTED | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 68 | |
| Overall Study | STARTED | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 75 | |
| Overall Study | STARTED | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 67 | |
| Overall Study | STARTED | 7-day Lopinavir/Ritonavir (LPV/r) | 71 | |
| Overall Study | STARTED | 21-day Lopinavir/Ritonavir (LPV/r) | 68 | |
| Overall Study | COMPLETED | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 72 | |
| Overall Study | COMPLETED | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 67 | |
| Overall Study | COMPLETED | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 72 | |
| Overall Study | COMPLETED | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 66 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events24
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 |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | 7-day 3TC/ZDV | 1 | 73 | |
| serious | Anaemia | Blood and lymphatic system disorders | 21-day 3TC/ZDV | 0 | 68 | |
| serious | Anaemia | Blood and lymphatic system disorders | 7-day FTC/TDF | 0 | 75 | |
| serious | Anaemia | Blood and lymphatic system disorders | 21-day FTC/TDF | 0 | 67 | |
| serious | Anaemia | Blood and lymphatic system disorders | 7-day LPV/r | 0 | 71 | |
| serious | Anaemia | Blood and lymphatic system disorders | 21-day LPV/r | 0 | 68 | |
| serious | Uterine rupture | Injury, poisoning and procedural complications | 7-day 3TC/ZDV | 1 | 73 | |
| serious | Uterine rupture | Injury, poisoning and procedural complications | 21-day 3TC/ZDV | 0 | 68 | |
| serious | Uterine rupture | Injury, poisoning and procedural complications | 7-day FTC/TDF | 0 | 75 | |
| serious | Uterine rupture | Injury, poisoning and procedural complications | 21-day FTC/TDF | 0 | 67 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 7-day 3TC/ZDV | ||
| Total, all-cause mortality | 21-day 3TC/ZDV | ||
| Total, all-cause mortality | 7-day FTC/TDF | ||
| Total, all-cause mortality | 21-day FTC/TDF | ||
| Total, all-cause mortality | 7-day LPV/r | ||
| Total, all-cause mortality | 21-day LPV/r | ||
| Total, other adverse events | 7-day 3TC/ZDV | 0 | 73 |
| Total, other adverse events | 21-day 3TC/ZDV | 0 | 68 |
| Total, other adverse events | 7-day FTC/TDF | 0 | 75 |
| Total, other adverse events | 21-day FTC/TDF | 0 | 67 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers6
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/NCT00099632
GET https://conductscience.org/api/trials/v1/NCT00099632/results?page=2