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| ID | Type | Description | Link |
|---|---|---|---|
| 10127 | Registry Identifier | DAIDS ES | |
| ACTG A5207 | |||
| MOMS |
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HIV infected pregnant women may take single-dose nevirapine (SD NVP) prior to giving birth to prevent mother-to-child transmission (MTCT) of HIV. However, SD NVP may cause NVP resistance in the mother, potentially ruling out some treatment options in the future. The purpose of this study is to determine which of three anti-HIV drug regimens most effectively reduces the development of maternal NVP resistance in HIV infected pregnant women. The effectiveness of short-term (7 day therapy) versus long-term (21-day therapy) regimens will also be compared.
The study hypotheses are: 1) intrapartum SD NVP with a 21-day course of antiretroviral therapy (ART) results in less frequent selection of NVP-resistant HIV-1 variants than intrapartum SD NVP with a 7-day course of ART, and 2) a 7- or 21-day course of lamivudine/zidovudine (3TC/ZDV), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), or lopinavir/ritonavir (LPV/r) following SD NVP will not select nucleoside reverse transcriptase inhibitor (NRTI)- or protease inhibitor (PI)- resistant HIV-1 variants.
A major disadvantage of giving SD NVP is the potential for maternal development of NVP resistance and additional resistance to other nonnucleoside reverse transcriptase inhibitors (NNRTI) in the mother; as a result, future treatment options may be limited for these HIV infected women. The purpose of the study is to determine which of three ART regimens most effectively deters the development of maternal NVP resistance in HIV infected pregnant women postpartum. This study also compared the effectiveness of short-term versus long-term ART in discouraging the development of maternal NVP resistance.
Some mothers in this study received ZDV monotherapy prior to SD NVP administration; initiation of ZDV monotherapy was at the discretion of the site investigator and was be provided by this study. Randomization was stratified by receipt of ZDV monotherapy during the pregnancy.
Prior to labor, mothers were randomly assigned to receive SD NVP at the onset of labor and one of three postpartum ART regimens: 3TC/ZDV, FTC/TDF, and LPV/r. In addition, participants were randomly assigned to receive 7 or 21 days of their assigned postpartum treatment.
Mothers were followed for 96 weeks following delivery; there were 11 study visits for mothers during the study. At the onset of labor, medical and medication history, a targeted physical exam, and an obstetrical exam occurred. Additional physical exams occurred on Day 1 and Weeks 1 and 3. Blood collection occurred at 8 study visits between Weeks 3 and 96. Infants were followed for up to 96 weeks after birth; there were 8 study visits for infants during the study. Infants who had ever been breastfed had study visits at Weeks 16, 24, 48, and 96, and at about 1 and 2 years of age. A physical exam, medication history, and blood collection occurred at each infant visit. Mothers and infants could be prescribed continuing ART, but such ART was be provided by this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7-day 3TC/ZDV | Experimental | SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV. |
|
| 21-day 3TC/ZDV | Experimental | SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV. |
|
| 7-day FTC/TDF | Experimental | SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF. |
|
| 21-day FTC/TDF | Experimental | SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF. |
|
| 7-day LPV/r | Experimental | SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emtricitabine/Tenofovir Disoproxil Fumarate | Drug | 200mg/300mg as one tablet taken orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping | 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. | 2 and 6 weeks after completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping. | 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. | 2 and 6 weeks after completion of treatment |
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Inclusion Criteria for Mothers:
Exclusion Criteria for Mothers:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Hitti, MD, MPH | Department of Obstetrics/Gynecology, Perinatal Medicine, University of Washington Medical Center | Study Chair |
| Deborah McMahon, MD | Division of Infectious Diseases, Department of Medicine, University of Pittsburgh | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS | Port-au-Prince | 6110 | Haiti | |||
| Byramjee Jeejeebhoy Government Medical College CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12134253 | Background | 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. | |
| 12152519 |
Not provided
Not provided
62 participants who randomized but did not start study treatment were excluded from the analysis. These 62 participants were either off study prior to delivery or delivered on study but did not take any dose of study treatment.
All the analyses were restricted to the 422 women who received study treatment.
Study participants were recruited at 8 sites: 2 from South Africa, 2 from India, and 1 each from Haiti, Uganda, Tanzania, and Malawi, between January 2007 to October 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | 7-day Lamivudine/Zidovudine (3TC/ZDV) | SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV. |
| FG001 | 21-day Lamivudine/Zidovudine (3TC/ZDV) | SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| 21-day LPV/r | Experimental | SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r |
|
| Lamivudine/Zidovudine | Drug | 150mg/300mg as one tablet taken orally twice daily |
|
|
| Lopinavir/Ritonavir | Drug | 133.3mg/33.3mg as three capsules taken orally twice daily |
|
|
| single dose Nevirapine | Drug | one 200 mg tablet taken orally |
|
|
| Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping. | 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. | 2 and 6 weeks after completion of treatment |
| 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 | 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 | From first day of study treatment to week 12 |
| Number of Participants Who Discontinued Study Treatment Prematurely | 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. | From first day of study treatment to last day of study treatment (up to 21 days) |
| Pune |
| Maharashtra |
| 411001 |
| India |
| Chennai Antiviral Research and Treatment (CART) CRS | Chennai | Tamil Nadu | 600113 | India |
| Blantyre CRS | Blantyre | Malawi |
| Wits Helen Joseph Hospital CRS (Wits HJH CRS) | Johannesburg | Gauteng | 2092 | South Africa |
| Durban International CRS | Westville | KwaZulu-Natal | 3610 | South Africa |
| Kilimanjaro Christian Medical CRS | Moshi | Tanzania |
| Joint Clinical Research Center (JCRC)/Kampala CRS | Kampala | Uganda |
| Background |
| Eshleman SH, Jackson JB. Nevirapine resistance after single dose prophylaxis. AIDS Rev. 2002 Apr-Jun;4(2):59-63. |
| 15247339 | Background | Jourdain G, Ngo-Giang-Huong N, Le Coeur S, Bowonwatanuwong C, Kantipong P, Leechanachai P, Ariyadej S, Leenasirimakul P, Hammer S, Lallemant M; Perinatal HIV Prevention Trial Group. Intrapartum exposure to nevirapine and subsequent maternal responses to nevirapine-based antiretroviral therapy. N Engl J Med. 2004 Jul 15;351(3):229-40. doi: 10.1056/NEJMoa041305. Epub 2004 Jul 9. |
| 15627034 | 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. |
| 14562860 | Background | Sullivan JL. Prevention of mother-to-child transmission of HIV--what next? J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S67-72. doi: 10.1097/00126334-200309011-00010. |
| Result | McMahon D, Noel F, Zheng L, Kabanda J, Halvas E, Taulo F, Kumarasamy N, Wallis C, Hughes M, Mellors J. Suppression of NVP Resistance with 7- vs 21-day ARV Regimens after Single-dose NVP: Results of A5207. Presented at 18th Conference on Retroviruses & Opportunistic Infections (CROI 11) on 03/01/2011 at Boston, MA |
| Result | Hong F, Halvas E, Chan E, Zheng L, Hughes M, Hitti J, McMahon D, Mellors J. Suppression of Minor NVP-Resistant Variants With 7- vs. 21-Day Antiretroviral Regimens After Single Dose Nevirapine. Presented at 20th Anniversary of the International Workshop on HIV & Hepatitis Virus Drug Resistance and Curative Strategies on Jun 9, 2011, Los Cabos, Mexico |
| 23300238 | Derived | McMahon DK, Zheng L, Hitti J, Chan ES, Halvas EK, Hong F, Kabanda J, Taulo F, Kumarasamy N, Bonhomme J, Wallis CL, Klingman KL, Hughes MD, Mellors JW. Greater suppression of nevirapine resistance with 21- vs 7-day antiretroviral regimens after intrapartum single-dose nevirapine for prevention of mother-to-child transmission of HIV. Clin Infect Dis. 2013 Apr;56(7):1044-51. doi: 10.1093/cid/cis1219. Epub 2013 Jan 8. |
| FG002 | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF. |
| FG003 | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF. |
| FG004 | 7-day Lopinavir/Ritonavir (LPV/r) | SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r. |
| FG005 | 21-day Lopinavir/Ritonavir (LPV/r) | SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 7-day Lamivudine/Zidovudine (3TC/ZDV) | SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV. |
| BG001 | 21-day Lamivudine/Zidovudine (3TC/ZDV) | SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV. |
| BG002 | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF. |
| BG003 | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF. |
| BG004 | 7-day Lopinavir/Ritonavir (LPV/r) | SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r. |
| BG005 | 21-day Lopinavir/Ritonavir (LPV/r) | SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Gestational age at NVP dosing, Continuous | Mean | Standard Deviation | weeks |
| |||||||||||||||
| Screening CD4 count Categorical | Number | participants |
| ||||||||||||||||
| Screening CD4 count Continuous | Mean | Standard Deviation | cells/mm^3 |
| |||||||||||||||
| Screening HIV-1 RNA Categorical | Number | participants |
| ||||||||||||||||
| Screening HIV-1 RNA Continuous | Mean | Standard Deviation | log10 copies/mL |
| |||||||||||||||
| Actual ZDV exposure during pregnancy | Number | participants |
|
| 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 | Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping | 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. | 412 women with primary endpoint results available | Posted | Number | participants | 2 and 6 weeks after completion of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping. | 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. | Posted | Number | participants | 2 and 6 weeks after completion of treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping. | 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. | Posted | Number | participants | 2 and 6 weeks after completion of treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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 | Posted | Number | participants | From first day of study treatment to week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Discontinued Study Treatment Prematurely | 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. | Posted | Number | participants | From first day of study treatment to last day of study treatment (up to 21 days) |
|
From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and >=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 7-day 3TC/ZDV | SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV | 2 | 73 | 0 | 73 | ||
| EG001 | 21-day 3TC/ZDV | SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV | 0 | 68 | 0 | 68 | ||
| EG002 | 7-day FTC/TDF | SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF | 1 | 75 | 0 | 75 | ||
| EG003 | 21-day FTC/TDF | SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF | 0 | 67 | 0 | 67 | ||
| EG004 | 7-day LPV/r | SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r | 1 | 71 | 0 | 71 | ||
| EG005 | 21-day LPV/r | SD NVP and LPV/r provided at onset of active labor, followed by 21 days of LPV/r | 0 | 68 | 0 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Uterine rupture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Intra-uterine death | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Systematic Assessment |
| |
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Systematic Assessment |
|
Not provided
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ACTG Clinicaltrials.gov Coordinator | ACTG Network Coordinating Center, Social and Scientific Systems, Inc. | (301) 628-3313 | ACTGCT.Gov@s-3.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C109078 | lamivudine, zidovudine drug combination |
| D061466 | Lopinavir |
| D019829 | Nevirapine |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D011744 | Pyrimidinones |
| D011725 | Pyridines |
Not provided
Not provided
| Between 20 and 29 years |
|
| Between 30 and 39 years |
|
| >= 40 years |
|
| Male |
|
| Tanzania |
|
| Uganda |
|
| South Africa |
|
| Malawi |
|
| India |
|
| 350-499 cells/mm^3 |
|
| >=500 cells/mm^3 |
|
| 401-999 copies/mL |
|
| 1000-9999 copies/mL |
|
| 10000-99999 copies/mL |
|
| 100000-749999 copies/mL |
|
| >=750000 copies/mL |
|
| Missing/Unknown |
|
| no |
|
| Compare proportion of women with new NNRTI-resistant variants among ARV regimens (3TC/ZDV vs. FTC/TDF vs. LPV/r), pooled over treatment durations 7-day and 21-day, stratified by treatment duration and the actual receipt of antenatal ZDV | Cochran-Mantel-Haenszel | Cochran-Mantel-Haenszel test stratified by treatment duration and the actual receipt of antenatal ZDV | 0.091 | 95 | Superiority or Other (legacy) |
| OG004 | 7-day Lopinavir/Ritonavir (LPV/r) | SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r. |
| OG005 | 21-day Lopinavir/Ritonavir (LPV/r) | SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r |
|
|
| OG004 | 7-day Lopinavir/Ritonavir (LPV/r) | SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r. |
| OG005 | 21-day Lopinavir/Ritonavir (LPV/r) | SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r |
|
|
SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
| OG004 | 7-day Lopinavir/Ritonavir (LPV/r) | SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r. |
| OG005 | 21-day Lopinavir/Ritonavir (LPV/r) | SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r |
|
|
| OG004 |
| 7-day Lopinavir/Ritonavir (LPV/r) |
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r. |
| OG005 | 21-day Lopinavir/Ritonavir (LPV/r) | SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r |
|
|