Reducing the Incidence of Nevirapine Resistance Mutations... | NCT00109590 | Trialant
NCT00109590
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Status
Completed
Last Update Posted
Nov 5, 2021Actual
Enrollment
175Actual
Phase
Phase 2
Conditions
HIV Infections
Interventions
Didanosine, enteric-coated
Lopinavir/ritonavir
Nevirapine
Zidovudine
Countries
Thailand
Protocol Section
Identification Module
NCT ID
NCT00109590
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
P1032
Secondary IDs
ID
Type
Description
Link
10137
Registry Identifier
DAIDS ES
PACTG P1032
Brief Title
Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth
Official Title
Phase II Study of the Pharmacokinetics of Nevirapine and the Incidence of Nevirapine Resistance Mutations in HIV-Infected Women Receiving a Single Intrapartum Dose of Nevirapine With the Concomitant Administration of Zidovudine/Didanosine or Zidovudine/Didanosine/Lopinavir/Ritonavir
Acronym
Not provided
Organization
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Status Module
Record Verification Date
Jan 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2006
Primary Completion Date
Oct 2008Actual
Completion Date
Nov 2009Actual
First Submitted Date
Apr 29, 2005
First Submission Date that Met QC Criteria
Apr 29, 2005
First Posted Date
May 2, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 26, 2012
Results First Submitted that Met QC Criteria
Nov 5, 2012
Results First Posted Date
Nov 6, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 20, 2010
Certification/Extension First Submitted that Passed QC Review
Jan 20, 2010
Certification/Extension First Posted Date
Jan 22, 2010Estimated
Last Update Submitted Date
Nov 3, 2021
Last Update Posted Date
Nov 5, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Collaborators
Name
Class
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this study is to determine which of 3 different anti-HIV drug regimens given to HIV infected pregnant women during and after their pregnancies is most effective in reducing the incidence of nevirapine (NVP) resistance mutations. Blood levels of NVP and lopinavir/ritonavir (LPV/r) will also be studied.
Study hypothesis: NVP resistance following single-dose NVP can be prevented with the concomitant administration of additional antiretroviral therapy (ART).
Detailed Description
A single dose of nevirapine (SD-NVP) given to an HIV infected pregnant woman in labor followed by a single dose to her infant had been shown to be a simple and effective means of reducing mother-to-child transmission (MTCT) of HIV among women who had not received antiretroviral (ART) during pregnancy. However, development of NVP and other nonnucleoside reverse transcriptase inhibitor (NNRTI)-resistant virus was a concern. An optimal ART regimen that can prevent selection of resistant virus while efficiently preventing MTCT was needed. This study evaluated 3 different ART strategies for preventing the development of NVP resistance in HIV infected pregnant women and compared the incidence of NVP resistance mutations postpartum observed with each regimen to the incidence among historical controls. NVP and LPV/r pharmacokinetics (PK) were also evaluated in this study.
Participants were randomly assigned to one of three study arms. All study participants received a single dose of oral NVP at the onset of labor and, oral zidovudine (ZDV) at the onset of labor, and every three hours during labor. Arm A: (LPV/r x 7d) participants received enteric-coated didanosine (ddI) and LPV/r orally twice daily beginning at the onset of labor and continuing through 7 days postpartum; oral ZDV was also taken twice daily for 7 days postpartum. Arm B: (no LPV/r) participants received enteric-coated ddI beginning at the onset of labor and continued through 30 days postpartum; oral ZDV was also taken twice daily for 30 days postpartum. Arm C : (LPV/r x 30d) participants received enteric-coated ddI and LPV/r orally twice daily beginning at the onset of labor and continued through 30 days postpartum; oral ZDV was also taken twice daily for 30 days postpartum.
All women were followed for at least 24 weeks postpartum. Women with resistance mutations identified within 8 weeks postpartum were to be followed until 72 weeks postpartum to evaluate the persistence of the mutations. All infants were followed until at least 12 weeks of age. HIV-infected infants were to be followed until 24 weeks of age. There were 11 study visits for women at day 10, 21, and 30 and week 5, 6, 8, 12, 24, 36, 48, and 72. Medical history assessment, a physical exam, and blood collection occurred at all visits. Blood collection for PK studies occurred at Days 10, 21, and 30. All women were asked to complete an adherence questionnaire at Day 10; women assigned to Arms A : LPV/r x 7d and B: no LPV/r were also asked to complete an adherence questionnaire at Day 30. There were 6 study visits for infants at birth - 48 hours, day 21, week 5, 12, 16 and 24. Medical history assessment and a physical exam occurred at most visits; blood collection occurred at all visits.
Data and specimens for the historical control comparison group were obtained from the PHPT-2 trial*, in which five of the P1032 study sites had participated between 2001 and 2003. PHPT-2 was a study of the efficacy of SD-NVP to prevent MTCT among women who received ZDV after 27 weeks gestation but no postpartum ART. Criteria for inclusion in the historical comparison group included receipt of SD-NVP, a CD4 count of more than 250 cells per cubic millimeter within 30 days of screening or entry, and the availability of plasma samples at 10 days or 6 weeks post-partum.
* Lallement M, Jourdain G, Le Coeur S, et al. Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand. N Engl J Med 2004; 351:217-28.
Conditions Module
Conditions
HIV Infections
Keywords
HIV Seronegativity
Treatment Naive
Pregnancy
Perinatal Transmission
Vertical Transmission
Mother-To-Child Transmission
MTCT
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
175Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm A: LPV/r x 7d
Experimental
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and BID for 7 days postpartum, ddI 250 mg orally daily (if body weight <60 kg) or 400 mg orally twice daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
Drug: Didanosine, enteric-coated
Drug: Lopinavir/ritonavir
Drug: Nevirapine
Drug: Zidovudine
Arm B: no LPV/r
Experimental
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum , ddI 250 mg orally daily (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
Drug: Didanosine, enteric-coated
Drug: Nevirapine
Drug: Zidovudine
Arm C: LPV/r x 30d
Experimental
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum , ddI 250 mg orally daily (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum,LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Drug: Didanosine, enteric-coated
Drug: Lopinavir/ritonavir
Drug: Nevirapine
Drug: Zidovudine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Didanosine, enteric-coated
Drug
once daily
Arm A: LPV/r x 7d
Arm B: no LPV/r
Arm C: LPV/r x 30d
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
The Proportion of Women Who Develop One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay in Plasma (Sampling Was Done at Days 10,21,30, and Weeks 5,6, and 8 Postpartum).
The incidence of new NVP resistance mutation in plasma HIV within 8 weeks postpartum in each randomized arm was estimated using an exact binomial confidence interval. If a resistance mutation was detected at any of the timepoints then an endpoint was met. Samples with VL <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml (e.g.missed visit), it was conservatively imputed as resistant in the primary analysis.
within 8 weeks postpartum.
The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay (OLA) in Plasma
The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis.
at Day 10 or Week 6 postpartum.
Area Under the Curve Pharmacokinetic Outcome for LPV/r. (AUC ug*hr/mL)
Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.
Within 72 hours postpartum and during the first 30 days postpartum
Maximum Concentration Pharmacokinetic Outcome for LPV/r (Cmax ug/mL) .
Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.
Secondary Outcomes
Measure
Description
Time Frame
The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations for the Subgroup of Women With Plasma HIV RNA >= 500 Copies/ml At Entry
The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria for Mothers:
HIV infected
Pregnant with a viable fetus
Between 28 and 38 weeks of pregnancy
CD4 count greater than 250 cells/mm3 within 30 days prior to study entry
Able to receive oral ART during labor
Willing to use acceptable forms of contraception while on study treatment
Able to provide written informed consent
Exclusion Criteria for Mothers:
Known allergy or hypersensitivity to ddI, LPV, NVP, ritonavir (RTV), or ZDV
Any ART other than ZDV during a previous pregnancy or the current pregnancy
Certain medications
Planning to receive additional ART during the first 8 weeks postpartum
Planning to breastfeed
Unlikely to comply with postpartum study requirements, in the opinion of the investigator
Certain abnormal laboratory values within 30 days prior to study entry
Accepts Healthy Volunteers
No
Sex
Female
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Russell Van Dyke, MD
Tulane University Medical School
Study Chair
Gonzague J. Jourdain, MD
Program for HIV Prevention and Treatment / IRD054, Department of Immunology and Infectious Diseases, Harvard School of Public Health
Cunningham CK, Chaix ML, Rekacewicz C, Britto P, Rouzioux C, Gelber RD, Dorenbaum A, Delfraissy JF, Bazin B, Mofenson L, Sullivan JL. Development of resistance mutations in women receiving standard antiretroviral therapy who received intrapartum nevirapine to prevent perinatal human immunodeficiency virus type 1 transmission: a substudy of pediatric AIDS clinical trials group protocol 316. J Infect Dis. 2002 Jul 15;186(2):181-8. doi: 10.1086/341300. Epub 2002 Jun 26.
The study recruited HIV infected pregnant women who were >= 18 years of age,>=28 to <38 weeks gestation, who did not plan to start antiretroviral treatment within eight weeks following delivery, not planning to breastfeed and had CD4+ count >250 cells/mm3. Women were randomized in approximately equal numbers to one of three treatment arms.
Recruitment Details
Study participants were enrolled at seven IMPAACT affiliated sites in Thailand. Between June 9, 2006 and June 30, 2008, 175 participants enrolled in the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm A : LPV/r x 7d
Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum,> Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Lopinavir/ritonavir
Drug
twice daily
Arm A: LPV/r x 7d
Arm C: LPV/r x 30d
Nevirapine
Drug
single-dose at the onset of labor
Arm A: LPV/r x 7d
Arm B: no LPV/r
Arm C: LPV/r x 30d
Zidovudine
Drug
twice daily
Arm A: LPV/r x 7d
Arm B: no LPV/r
Arm C: LPV/r x 30d
Within 72 hours postpartum and during the first 30 days postpartum
Pre-dose Concentration Pharmacokinetic Outcome for LPV/r (Cpredose ug/mL).
Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.
Within 72 hours postpartum and during the first 30 days postpartum
Four (4) Hour Concentration Pharmacokinetic Outcome for LPV/r (C4hour ug/mL).
Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.
Within 72 hours postpartum and during the first 30 days postpartum
at Day 10 or Week 6 postpartum.
The Proportion of Women With Any New ZDV, ddI, or LPV/r Resistance Mutations.
At Week 5 postpartum (ZDV) and at the first timepoint with viral load >=500 copies/ml after treatment discontinuation (ddI and LPV/r).
Number of Women With Grade >=3 Events After Start of Study Treatment
Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading > the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities (and events of any grade that led to a change in study treatment) were included.
After start of study Treatment (postpartum)
Proportion of Women With New NVP Resistance Mutation Within 8 Weeks Postpartum Who Had a NVP Resistance Mutation Detected at 72 Weeks Postpartum.
Resistance mutations as identified by OLA in plasma samples or PBMC at 72 weeks postpartum amongst women who had new NVP resistance mutations within 8 weeks postpatrum. These results were based on the 13 women who developed a new NVP resistance mutation in the first 8 weeks postpartum. For the primary outcome measure 1, one particpant in arm A was unavailable for follow-up after week 5 and was conservatively imputed to have developed resistance mutation.
within 72 weeks postpartum
Resistance Mutations in HIV Infected Infants
Resistance mutations as identified by consensus sequencing or OLA
24 weeks postpartum
Median HIV-1 Viral Load at 24 Weeks Postpartum in Women
at 24 weeks postpartum
Bangkok
Bangkoknoi
10700
Thailand
Prapokklao Hosp. CRS
Chanthaburi
22000
Thailand
Chiang Mai University Pediatrics-Obstetrics CRS
Chiang Mai
50200
Thailand
Chiangrai Prachanukroh Hospital CRS
Chiangrai
57000
Thailand
Chonburi Hosp. CRS
Chon Buri
20000
Thailand
Phayao Provincial Hosp. CRS
Phayao
56000
Thailand
Background
Lyons FE, Coughlan S, Byrne CM, Hopkins SM, Hall WW, Mulcahy FM. Emergence of antiretroviral resistance in HIV-positive women receiving combination antiretroviral therapy in pregnancy. AIDS. 2005 Jan 3;19(1):63-7. doi: 10.1097/00002030-200501030-00007.
Cressey TR, Van Dyke R, Jourdain G, Puthanakit T, Roongpisuthipong A, Achalapong J, Yuthavisuthi P, Prommas S, Chotivanich N, Maupin R, Smith E, Shapiro DE, Mirochnick M; IMPAACT P1032 Team. Early postpartum pharmacokinetics of lopinavir initiated intrapartum in Thai women. Antimicrob Agents Chemother. 2009 May;53(5):2189-91. doi: 10.1128/AAC.01091-08. Epub 2009 Feb 23.
Van Dyke RB, Ngo-Giang-Huong N, Shapiro DE, Frenkel L, Britto P, Roongpisuthipong A, Beck IA, Yuthavisuthi P, Prommas S, Puthanakit T, Achalapong J, Chotivanich N, Rasri W, Cressey TR, Maupin R, Mirochnick M, Jourdain G; IMPAACT P1032 Protocol Team. A comparison of 3 regimens to prevent nevirapine resistance mutations in HIV-infected pregnant women receiving a single intrapartum dose of nevirapine. Clin Infect Dis. 2012 Jan 15;54(2):285-93. doi: 10.1093/cid/cir798. Epub 2011 Dec 5.
FG001
Arm B : no LPV/r
Neviarpine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally once daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
FG002
Arm C: LPV/r x 30d
Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
FG00057 subjects
FG00158 subjects
FG00260 subjects
RECEIVED TREATMENT
FG00056 subjects
FG00156 subjects
FG00257 subjects
COMPLETED
FG00055 subjects
FG00156 subjects
FG00256 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0024 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0021 subjects
Never Started Treatment
FG0001 subjects
FG0012 subjects
FG0023 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm A : LPV/r x 7d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
BG001
Arm B : no LPV/r
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
BG002
Arm C: LPV/r x 30d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00056
BG00156
BG00257
BG003169
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00027± 6
BG00128± 5
BG00227± 5
BG003
Age, Customized
Number
participants
Title
Denominators
Categories
18 to < 30years
Title
Measurements
BG00034
BG00135
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00056
BG00156
BG002
Gestational Age at Entry
Median
Full Range
weeks
Title
Denominators
Categories
Title
Measurements
BG00032(28 to 37)
BG00131(27 to 38)
BG002
Duration of ZDV during pregnancy - At Entry
Median
Full Range
weeks
Title
Denominators
Categories
Title
Measurements
BG0003(0 to 9)
BG0012(0 to 10)
BG002
Duration of ZDV during pregnancy - At Delivery
Median
Full Range
weeks
Title
Denominators
Categories
Title
Measurements
BG00010(2 to 16)
BG00111(5 to 18)
BG002
CD4 cell count at entry
Median
Full Range
cells/uL
Title
Denominators
Categories
Title
Measurements
BG000431(262 to 1233)
BG001413(251 to 1024)
BG002
CD4 cell count at delivery
Median
Full Range
cells/uL
Title
Denominators
Categories
Title
Measurements
BG000484(70 to 1001)
BG001517(198 to 1150)
BG002
Plasma HIV RNA at entry
Median
Full Range
log10 copies/mL
Title
Denominators
Categories
Title
Measurements
BG0003.48(2.60 to 4.98)
BG0013.52(1.00 to 4.99)
BG002
Plasma HIV-RNA at delivery
Median
Full Range
log10 copies/mL
Title
Denominators
Categories
Title
Measurements
BG0003.63(1.70 to 4.90)
BG0013.36(1.70 to 4.83)
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
The Proportion of Women Who Develop One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay in Plasma (Sampling Was Done at Days 10,21,30, and Weeks 5,6, and 8 Postpartum).
The incidence of new NVP resistance mutation in plasma HIV within 8 weeks postpartum in each randomized arm was estimated using an exact binomial confidence interval. If a resistance mutation was detected at any of the timepoints then an endpoint was met. Samples with VL <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml (e.g.missed visit), it was conservatively imputed as resistant in the primary analysis.
All women who started treatment were included in an intention-to-treat analysis.
Posted
Number
95% Confidence Interval
percent of participants
within 8 weeks postpartum.
ID
Title
Description
OG000
Arm A : LPV/r x 7d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
OG001
Arm B : no LPV/r
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
OG002
Arm C: LPV/r x 30d
NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Units
Counts
Participants
OG00056
OG00156
OG00257
Title
Denominators
Categories
Title
Measurements
OG0007.1(2.0 to 17.3)
OG00112.5(5.2 to 24.1)
OG0025.3(1.1 to 14.6)
Primary
The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay (OLA) in Plasma
The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis.
All women who started treatment were included in an intention-to-treat analysis (according to randomized treatment assignment, regardless of compliance with the protocol)
Posted
Number
95% Confidence Interval
percent of participants
at Day 10 or Week 6 postpartum.
ID
Title
Description
OG000
Arm A : LPV/r x 7d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
OG001
Arm B : no LPV/r
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
Primary
Area Under the Curve Pharmacokinetic Outcome for LPV/r. (AUC ug*hr/mL)
Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.
18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.
Posted
Median
Full Range
ug*hr/mL
Within 72 hours postpartum and during the first 30 days postpartum
ID
Title
Description
OG000
Within 72 Hrs Ppm
ZDV, ddI, LPV/r x 30d
OG001
At Day 30 Ppm
ZDV, ddI, LPV/r x 30d
Units
Counts
Participants
Secondary
The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations for the Subgroup of Women With Plasma HIV RNA >= 500 Copies/ml At Entry
The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis.
Includes only the Subgroup of women with Plasma HIV RNA >= 500 copies/ml at Entry and who started treatment; analyzed using the intention-to-treat principle (according to assigned treatment, regardless of compliance with the protocol).
Posted
Number
95% Confidence Interval
percent of participants
at Day 10 or Week 6 postpartum.
ID
Title
Description
OG000
Arm A: LPV/r x 7d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7days postpartum.
OG001
Arm B: no LPV/r
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
Secondary
The Proportion of Women With Any New ZDV, ddI, or LPV/r Resistance Mutations.
All women who started treatment were included in an intention-to-treat analysis
Posted
Number
percent of participants
At Week 5 postpartum (ZDV) and at the first timepoint with viral load >=500 copies/ml after treatment discontinuation (ddI and LPV/r).
ID
Title
Description
OG000
Arm A : LPV/r x 7d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
OG001
Arm B : no LPV/r
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
OG002
Arm C: LPV/r x 30d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Secondary
Number of Women With Grade >=3 Events After Start of Study Treatment
Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading > the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities (and events of any grade that led to a change in study treatment) were included.
All women who started treatment were included in an intention-to-treat analysis.
Posted
Number
participants
After start of study Treatment (postpartum)
ID
Title
Description
OG000
Arm A : LPV/r x 7d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
OG001
Arm B : no LPV/r
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
OG002
Secondary
Proportion of Women With New NVP Resistance Mutation Within 8 Weeks Postpartum Who Had a NVP Resistance Mutation Detected at 72 Weeks Postpartum.
Resistance mutations as identified by OLA in plasma samples or PBMC at 72 weeks postpartum amongst women who had new NVP resistance mutations within 8 weeks postpatrum. These results were based on the 13 women who developed a new NVP resistance mutation in the first 8 weeks postpartum. For the primary outcome measure 1, one particpant in arm A was unavailable for follow-up after week 5 and was conservatively imputed to have developed resistance mutation.
amongst the participants who developed resistance within 8 weeks postpartum
Posted
Number
participants
within 72 weeks postpartum
ID
Title
Description
OG000
Arm A : LPV/r x 7d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
OG001
Arm B : no LPV/r
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
Secondary
Resistance Mutations in HIV Infected Infants
Resistance mutations as identified by consensus sequencing or OLA
Amongst the infants who became HIV-infected.
Posted
Number
participants
24 weeks postpartum
ID
Title
Description
OG000
Arm A : LPV/r x 7d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
OG001
Arm B : no LPV/r
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
OG002
Arm C: LPV/r x 30d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Secondary
Median HIV-1 Viral Load at 24 Weeks Postpartum in Women
The number of particpants included in this analyses were for those for whom viral loads were available at 24 weeeks postpartum.
Posted
Median
Full Range
log10 copies/mL
at 24 weeks postpartum
ID
Title
Description
OG000
Arm A : LPV/r x 7d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally QD (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
OG001
Arm B : no LPV/r
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
OG002
Arm C: LPV/r x 30d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Primary
Maximum Concentration Pharmacokinetic Outcome for LPV/r (Cmax ug/mL) .
Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.
18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.
Posted
Median
Full Range
ug/mL
Within 72 hours postpartum and during the first 30 days postpartum
ID
Title
Description
OG000
Within 72 Hrs Ppm
ZDV, ddI, LPV/r x 30d
OG001
At Day 30 Ppm
ZDV, ddI, LPV/r x 30d
Units
Counts
Participants
Primary
Pre-dose Concentration Pharmacokinetic Outcome for LPV/r (Cpredose ug/mL).
Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.
18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.
Posted
Median
Full Range
ug/mL
Within 72 hours postpartum and during the first 30 days postpartum
ID
Title
Description
OG000
Within 72 Hrs Ppm
ZDV, ddI, LPV/r x 30d
OG001
At Day 30 Ppm
ZDV, ddI, LPV/r x 30d
Units
Counts
Participants
Primary
Four (4) Hour Concentration Pharmacokinetic Outcome for LPV/r (C4hour ug/mL).
Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.
18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.
Posted
Median
Full Range
ug/mL
Within 72 hours postpartum and during the first 30 days postpartum
ID
Title
Description
OG000
Within 72 Hrs Ppm
ZDV, ddI, LPV/r x 30d
OG001
At Day 30 Ppm
ZDV, ddI, LPV/r x 30d
Units
Counts
Participants
Time Frame
Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason.
Description
Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade >=3 for mothers or grade >=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Mother: LPV/r x 7d
NVP 200 mg orally, single dose at onset
0
56
33
56
EG001
Mother: no LPV/r
ZDV & ddI x 30d
1
56
43
56
EG002
Mother: LPV/r x 30d
ZDV, ddI, LPV/r x 30d
2
57
45
57
EG003
Infant: LPV/r x 7d
NVP 200 mg orally, single dose at onset
34
56
48
56
EG004
Infant: no LPV/r
ZDV & ddI x 30d
32
57
51
57
EG005
Infant: LPV/r x 30d
ZDV, ddI, LPV/r x 30d
33
57
49
57
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0022 affected57 at risk
EG00317 affected56 at risk
EG0048 affected57 at risk
EG00510 affected57 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Neutropenia neonatal
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
ABO haemolytic disease of newborn
Congenital, familial and genetic disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Congenital hypothyroidism
Congenital, familial and genetic disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Fallot's tetralogy
Congenital, familial and genetic disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Phimosis
Congenital, familial and genetic disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Pulmonary artery stenosis congenital
Congenital, familial and genetic disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Trisomy 21
Congenital, familial and genetic disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Ventricular septal defect
Congenital, familial and genetic disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Conjunctival hyperaemia
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Duodenal stenosis
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Pyrexia
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0011 affected56 at risk
EG0020 affected57 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Allergy to arthropod bite
Immune system disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Blood calcium increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Blood creatine increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Blood glucose decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Blood potassium increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Blood sodium increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Heart rate increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Platelet count decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
White blood cell count increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Hypoglycaemia neonatal
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Neonatal hyponatraemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Cephalhaematoma
Pregnancy, puerperium and perinatal conditions
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Jaundice neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Premature baby
Pregnancy, puerperium and perinatal conditions
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Small for dates baby
Pregnancy, puerperium and perinatal conditions
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Umbilical granuloma
Pregnancy, puerperium and perinatal conditions
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Neonatal asphyxia
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Neonatal respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Neonatal tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Heat rash
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG00311 affected56 at risk
EG00415 affected57 at risk
EG00512 affected57 at risk
Anaemia neonatal
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 14.0
Systematic Assessment
EG0003 affected56 at risk
EG0012 affected56 at risk
EG0020 affected57 at risk
EG003
Conjunctival discolouration
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Eye discharge
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0002 affected56 at risk
EG0013 affected56 at risk
EG0022 affected57 at risk
EG003
Diarrhoea neonatal
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 affected56 at risk
EG0014 affected56 at risk
EG0022 affected57 at risk
EG003
Pyrexia
General disorders
MedDRA 14.0
Systematic Assessment
EG0006 affected56 at risk
EG0019 affected56 at risk
EG0028 affected57 at risk
EG003
Secretion discharge
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
ABO incompatibility
Immune system disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0013 affected56 at risk
EG0021 affected57 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0002 affected56 at risk
EG0015 affected56 at risk
EG0026 affected57 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0001 affected56 at risk
EG0014 affected56 at risk
EG0022 affected57 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0001 affected56 at risk
EG0016 affected56 at risk
EG0023 affected57 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0013 affected56 at risk
EG0020 affected57 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0003 affected56 at risk
EG0014 affected56 at risk
EG0022 affected57 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0002 affected56 at risk
EG0012 affected56 at risk
EG0024 affected57 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0002 affected56 at risk
EG0015 affected56 at risk
EG0021 affected57 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0004 affected56 at risk
EG0017 affected56 at risk
EG0025 affected57 at risk
EG003
Blood bicarbonate abnormal
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0002 affected56 at risk
EG0011 affected56 at risk
EG0023 affected57 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Blood glucose abnormal
Investigations
MedDRA 14.0
Systematic Assessment
EG0003 affected56 at risk
EG0014 affected56 at risk
EG0022 affected57 at risk
EG003
Blood glucose decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0006 affected56 at risk
EG0013 affected56 at risk
EG0023 affected57 at risk
EG003
Blood glucose increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0008 affected56 at risk
EG0013 affected56 at risk
EG0027 affected57 at risk
EG003
Blood potassium increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Cardiac murmur
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Haemoglobin abnormal
Investigations
MedDRA 14.0
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected56 at risk
EG0022 affected57 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG00015 affected56 at risk
EG00116 affected56 at risk
EG00221 affected57 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0001 affected56 at risk
EG0012 affected56 at risk
EG0024 affected57 at risk
EG003
Platelet count decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0004 affected56 at risk
EG0012 affected56 at risk
EG0022 affected57 at risk
EG003
Hypoglycaemia neonatal
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Hypothermia neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Jaundice neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Small for dates baby
Pregnancy, puerperium and perinatal conditions
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Umbilical granuloma
Pregnancy, puerperium and perinatal conditions
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0012 affected56 at risk
EG0026 affected57 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 14.0
Systematic Assessment
EG0003 affected56 at risk
EG0013 affected56 at risk
EG0020 affected57 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0023 affected57 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0003 affected56 at risk
EG0017 affected56 at risk
EG0023 affected57 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0011 affected56 at risk
EG0020 affected57 at risk
EG003
Neonatal tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0002 affected56 at risk
EG0017 affected56 at risk
EG0022 affected57 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0004 affected56 at risk
EG0016 affected56 at risk
EG0023 affected57 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0001 affected56 at risk
EG0014 affected56 at risk
EG0024 affected57 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0011 affected56 at risk
EG0021 affected57 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0011 affected56 at risk
EG0020 affected57 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0021 affected57 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Pallor
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected56 at risk
EG0020 affected57 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights".
Point of Contact
Title
Organization
Phone
Extension
Email
Melissa Allen, Director, IMPAACT Operations Center
Family Health International (FHI 360)
(919) 405-1429
mallen@fhi360.org
ID
Term
D015658
HIV Infections
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D015229
Sexually Transmitted Diseases, Viral
D012749
Sexually Transmitted Diseases
D016180
Lentivirus Infections
D012192
Retroviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D007153
Immunologic Deficiency Syndromes
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D016049
Didanosine
D061466
Lopinavir
D019829
Nevirapine
D015215
Zidovudine
Ancestor Terms
ID
Term
D007288
Inosine
D011684
Purine Nucleosides
D011687
Purines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
D015224
Dideoxynucleosides
D003853
Deoxyribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D012263
Ribonucleosides
D011744
Pyrimidinones
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D011725
Pyridines
D013936
Thymidine
D011741
Pyrimidine Nucleosides
Browse Leaves
Not provided
Browse Branches
Not provided
28
± 5
38
BG003107
>=30 to < 45 years
Title
Measurements
BG00021
BG00121
BG00219
BG00361
>= 45 years
Title
Measurements
BG0001
BG0010
BG0020
BG0031
57
BG003169
Male
BG0000
BG0010
BG0020
BG0030
31
(28 to 37)
BG00331(27 to 38)
2
(0 to 27)
BG0033(0 to 27)
10
(0 to 31)
BG00310(0 to 31)
481
(262 to 1183)
BG003456(251 to 1233)
566
(222 to 1182)
BG003513(70 to 1182)
3.54
(2.60 to 5.05)
BG0033.49(1.00 to 5.05)
3.48
(1.70 to 4.71)
BG0033.48(1.70 to 4.90)
OG002
Arm C : LPV/r x 30d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Units
Counts
Participants
OG00056
OG00156
OG00257
Title
Denominators
Categories
Title
Measurements
OG0003.6(0.5 to 12.3)
OG0017.1(2.0 to 17.3)
OG0025.3(1.1 to 14.6)
OG000
16
OG00114
Title
Denominators
Categories
Title
Measurements
OG00099.7(66.3 to 180.5)
OG001NA(NA to NA)Only 3 samples were collected at 30 days postpartum for PK assessment (pre-dose, 2 hours and 4 hours post-dose) and with these limited number of samples it was not possible to have a good estimate of the AUC and Cmax.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The null hypothesis was that there was no difference in within-subject Cpredose LPV/r plasma drug concentrations within 72 hours after delivery versus at 30 days postpartum.
wilcoxon Signed Rank Test
0.009
The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was two-sided P<0.05.
95
Superiority or Other (legacy)
OG000
OG001
The null hypothesis was that there was no difference in within-subject C4hour LPV/r plasma drug concentrations within 72 hours after delivery versus at 30 days postpartum
Wilcoxon Signed Rank Test
0.048
The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was two-sided P<0.05.
95
Superiority or Other (legacy)
OG002
Arm C : LPV/r x 30d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Units
Counts
Participants
OG00041
OG00142
OG00243
Title
Denominators
Categories
Title
Measurements
OG0004.9(0.6 to 16.6)
OG0019.5(2.7 to 22.6)
OG0027.0(1.5 to 19.1)
Units
Counts
Participants
OG00056
OG00156
OG00257
Title
Denominators
Categories
The proportion of women with new ZDV resistance
Title
Measurements
OG0000
OG0011.78
OG0020
The proportion of women with new ddI resistance
Title
Measurements
OG0000
OG0010
OG0020
The proportion of women with new LPV/r resistance
Title
Measurements
OG0000
OG0010
OG0020
Arm C: LPV/r x 30d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Units
Counts
Participants
OG00056
OG00156
OG00257
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0022
OG002
Arm C: LPV/r x 30d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Units
Counts
Participants
OG0003
OG0017
OG0023
Title
Denominators
Categories
OLA in plasma samples
Title
Measurements
OG0000
OG0010
OG0020
OLA in PBMC
Title
Measurements
OG0000
OG0010
OG0021
Units
Counts
Participants
OG0000
OG0011
OG0021
Title
Denominators
Categories
Title
Measurements
OG0010
OG0020
Units
Counts
Participants
OG00054
OG00155
OG00254
Title
Denominators
Categories
Title
Measurements
OG0004.3(1.7 to 5.7)
OG0013.9(1.7 to 5.3)
OG0024.0(1.7 to 5.2)
OG000
16
OG00114
Title
Denominators
Categories
Title
Measurements
OG00011.2(8.0 to 17.5)
OG001NA(NA to NA)Only 3 samples were collected at 30 days postpartum for PK assessment (pre-dose, 2 hours and 4 hours post-dose) and with these limited number of samples it was not possible to have a good estimate of the Cmax.