Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy
NCT ID: NCT00099632
Last Updated: 2021-11-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
484 participants
INTERVENTIONAL
2006-03-31
2011-11-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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7-day 3TC/ZDV
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
Lamivudine/Zidovudine
150mg/300mg as one tablet taken orally twice daily
single dose Nevirapine
one 200 mg tablet taken orally
21-day 3TC/ZDV
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
Lamivudine/Zidovudine
150mg/300mg as one tablet taken orally twice daily
single dose Nevirapine
one 200 mg tablet taken orally
7-day FTC/TDF
SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
Emtricitabine/Tenofovir Disoproxil Fumarate
200mg/300mg as one tablet taken orally once daily
single dose Nevirapine
one 200 mg tablet taken orally
21-day FTC/TDF
SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
Emtricitabine/Tenofovir Disoproxil Fumarate
200mg/300mg as one tablet taken orally once daily
single dose Nevirapine
one 200 mg tablet taken orally
7-day LPV/r
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
Lopinavir/Ritonavir
133.3mg/33.3mg as three capsules taken orally twice daily
single dose Nevirapine
one 200 mg tablet taken orally
21-day LPV/r
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
Lopinavir/Ritonavir
133.3mg/33.3mg as three capsules taken orally twice daily
single dose Nevirapine
one 200 mg tablet taken orally
Interventions
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Emtricitabine/Tenofovir Disoproxil Fumarate
200mg/300mg as one tablet taken orally once daily
Lamivudine/Zidovudine
150mg/300mg as one tablet taken orally twice daily
Lopinavir/Ritonavir
133.3mg/33.3mg as three capsules taken orally twice daily
single dose Nevirapine
one 200 mg tablet taken orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* CD4 count 250 cells/mm3 or greater within 30 days of study entry
* The following laboratory values obtained within 30 days prior to study entry: absolute neutropil count \>= 750/mm3; hemoglobin \>= 8.0 g/dL; platelet count \>= 50,000/mm3; calculated creatinine clearance (Cockcroft-Gault formula) \> 60 mL/min; AST(SGOT) and ALT(SGPT) \< 5 x ULN; total bilirubin \< 1.5 X ULN.
* Pregnant with a viable fetus at 28 to 38 weeks gestation at study entry.
* Willing to give birth to baby in a hospital or clinic
* Written informed consent from parent or guardian, if applicable
Exclusion Criteria
* Known allergy or sensitivity to study drugs or their formulations
* Current drug or alcohol abuse that may interfere with the study
* Serious illness requiring systemic treatment or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
* Hepatitis B surface antigen positive within 180 days prior to study entry
* Active tuberculosis infection requiring treatment
* Prior enrollment in this study
* Expect to use ART, except ZDV monotherapy, prior to onset of labor
* Expect to use ART other than study medications from delivery to 9 weeks postpartum
13 Years
FEMALE
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Jane Hitti, MD, MPH
Role: STUDY_CHAIR
Department of Obstetrics/Gynecology, Perinatal Medicine, University of Washington Medical Center
Deborah McMahon, MD
Role: STUDY_CHAIR
Division of Infectious Diseases, Department of Medicine, University of Pittsburgh
Locations
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Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
Port-au-Prince, , Haiti
Byramjee Jeejeebhoy Government Medical College CRS
Pune, Maharashtra, India
Chennai Antiviral Research and Treatment (CART) CRS
Chennai, Tamil Nadu, India
Blantyre CRS
Blantyre, , Malawi
Wits Helen Joseph Hospital CRS (Wits HJH CRS)
Johannesburg, Gauteng, South Africa
Durban International CRS
Westville, KwaZulu-Natal, South Africa
Kilimanjaro Christian Medical CRS
Moshi, , Tanzania
Joint Clinical Research Center (JCRC)/Kampala CRS
Kampala, , Uganda
Countries
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References
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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.
Eshleman SH, Jackson JB. Nevirapine resistance after single dose prophylaxis. AIDS Rev. 2002 Apr-Jun;4(2):59-63.
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.
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.
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.
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
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
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.
Other Identifiers
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10127
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5207
Identifier Type: -
Identifier Source: secondary_id
MOMS
Identifier Type: -
Identifier Source: secondary_id
A5207
Identifier Type: -
Identifier Source: org_study_id