Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00099632

First received: December 17, 2004

Last updated: May 17, 2012

Last verified: May 2012

History of Changes

Results First Received: December 6, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	HIV Infections
Interventions:	Drug: Emtricitabine/Tenofovir Disoproxil Fumarate Drug: Lamivudine/Zidovudine Drug: Lopinavir/Ritonavir Drug: single dose Nevirapine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

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.

Reporting Groups

	Description
7-day Lamivudine/Zidovudine (3TC/ZDV)	SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
21-day Lamivudine/Zidovudine (3TC/ZDV)	SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
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.
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.
7-day Lopinavir/Ritonavir (LPV/r)	SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
21-day Lopinavir/Ritonavir (LPV/r)	SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r

Participant Flow: Overall Study

	7-day Lamivudine/Zidovudine (3TC/ZDV)	21-day Lamivudine/Zidovudine (3TC/ZDV)	7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	7-day Lopinavir/Ritonavir (LPV/r)	21-day Lopinavir/Ritonavir (LPV/r)
STARTED	73	68	75	67	71	68
COMPLETED	72	67	72	66	70	66
NOT COMPLETED	1	1	3	1	1	2
Lost to Follow-up	1	0	3	1	1	0
Withdrawal by Subject	0	1	0	0	0	1
Protocol Violation	0	0	0	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
7-day Lamivudine/Zidovudine (3TC/ZDV)	SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
21-day Lamivudine/Zidovudine (3TC/ZDV)	SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
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.
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.
7-day Lopinavir/Ritonavir (LPV/r)	SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
21-day Lopinavir/Ritonavir (LPV/r)	SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
Total	Total of all reporting groups

Baseline Measures

	7-day Lamivudine/Zidovudine (3TC/ZDV)	21-day Lamivudine/Zidovudine (3TC/ZDV)	7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	7-day Lopinavir/Ritonavir (LPV/r)	21-day Lopinavir/Ritonavir (LPV/r)	Total
Number of Participants [units: participants]	73	68	75	67	71	68	422
Age [units: years] Mean ± Standard Deviation	27 ± 6	27 ± 5	26 ± 5	26 ± 5	27 ± 6	26 ± 5	27 ± 5
Age, Customized [units: participants]
Between 13 and 19 years	2	1	5	3	3	3	17
Between 20 and 29 years	49	46	53	46	47	48	289
Between 30 and 39 years	20	20	16	18	19	16	109
>= 40 years	2	1	1	0	2	1	7
Gender [units: participants]
Female	73	68	75	67	71	68	422
Male	0	0	0	0	0	0	0
Region of Enrollment [units: participants]
Haiti	12	11	10	7	9	9	58
Tanzania	3	1	3	3	2	2	14
Uganda	17	16	18	17	17	16	101
South Africa	13	8	10	9	10	10	60
Malawi	13	14	14	12	17	15	85
India	15	18	20	19	16	16	104
Gestational age at NVP dosing, Continuous [units: weeks] Mean ± Standard Deviation	38 ± 2	39 ± 2	38 ± 2	38 ± 3	38 ± 2	38 ± 2	38 ± 2
Screening CD4 count Categorical [units: participants]
250-349 cells/mm^3	15	7	8	6	20	13	69
350-499 cells/mm^3	24	21	29	29	25	22	150
>=500 cells/mm^3	34	40	38	32	26	33	203
Screening CD4 count Continuous [units: cells/mm^3] Mean ± Standard Deviation	538 ± 244	585 ± 215	537 ± 186	545 ± 191	505 ± 205	566 ± 249	545 ± 216
Screening HIV-1 RNA Categorical [units: participants]
<=400 copies/mL	17	13	13	12	12	16	83
401-999 copies/mL	12	8	7	11	6	4	48
1000-9999 copies/mL	17	26	33	25	29	18	148
10000-99999 copies/mL	17	17	18	14	20	26	112
100000-749999 copies/mL	8	3	4	5	4	4	28
>=750000 copies/mL	1	0	0	0	0	0	1
Missing/Unknown	1	1	0	0	0	0	2
Screening HIV-1 RNA Continuous [units: log10 copies/mL] Mean ± Standard Deviation	3.50 ± 1.01	3.55 ± 0.90	3.54 ± 0.82	3.50 ± 0.88	3.63 ± 0.90	3.66 ± 0.92	3.56 ± 0.90
Actual ZDV exposure during pregnancy [units: participants]
yes	46	47	47	42	43	42	267
no	27	21	28	25	28	26	155

Outcome Measures

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1. Primary:

Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping [ Time Frame: 2 and 6 weeks after completion of treatment ]

Measure Type	Primary
Measure Title	Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping
Measure Description	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.
Time Frame	2 and 6 weeks after completion of treatment
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
412 women with primary endpoint results available

Reporting Groups

	Description
7-day Lamivudine/Zidovudine (3TC/ZDV)	SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
21-day Lamivudine/Zidovudine (3TC/ZDV)	SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
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.
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.
7-day Lopinavir/Ritonavir (LPV/r)	SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
21-day Lopinavir/Ritonavir (LPV/r)	SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r

Measured Values

	7-day Lamivudine/Zidovudine (3TC/ZDV)	21-day Lamivudine/Zidovudine (3TC/ZDV)	7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	7-day Lopinavir/Ritonavir (LPV/r)	21-day Lopinavir/Ritonavir (LPV/r)
Number of Participants Analyzed [units: participants]	73	67	71	65	71	65
Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping [units: participants]	1	0	0	0	3	1

Statistical Analysis 1 for Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping

Groups ^[1]	All groups
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	0.37

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Compare proportion of women with new NNRTI-resistant variants between treatment durations (7-day vs. 21 day), pooled over ARV regimens (3TC/ZDV, FTC/TDF, and LPV/r), stratified by ARV regimen and the actual receipt of antenatal ZDV
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Cochran-Mantel-Haenszel test stratified by ARV regimen and the actual receipt of antenatal ZDV
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping

Groups ^[1]	All groups
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	0.091

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Cochran-Mantel-Haenszel test stratified by treatment duration and the actual receipt of antenatal ZDV
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

2. Secondary:

Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping. [ Time Frame: 2 and 6 weeks after completion of treatment ]

Measure Type	Secondary
Measure Title	Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping.
Measure Description	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.
Time Frame	2 and 6 weeks after completion of treatment
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
7-day Lamivudine/Zidovudine (3TC/ZDV)	SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
21-day Lamivudine/Zidovudine (3TC/ZDV)	SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
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.
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.
7-day Lopinavir/Ritonavir (LPV/r)	SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
21-day Lopinavir/Ritonavir (LPV/r)	SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r

Measured Values

	7-day Lamivudine/Zidovudine (3TC/ZDV)	21-day Lamivudine/Zidovudine (3TC/ZDV)	7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	7-day Lopinavir/Ritonavir (LPV/r)	21-day Lopinavir/Ritonavir (LPV/r)
Number of Participants Analyzed [units: participants]	73	67	71	65	71	65
Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping. [units: participants]	0	1	1	1	1	0

No statistical analysis provided for Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping.

3. Secondary:

Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping. [ Time Frame: 2 and 6 weeks after completion of treatment ]

Measure Type	Secondary
Measure Title	Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping.
Measure Description	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.
Time Frame	2 and 6 weeks after completion of treatment
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
7-day Lamivudine/Zidovudine (3TC/ZDV)	SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
21-day Lamivudine/Zidovudine (3TC/ZDV)	SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
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.
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.
7-day Lopinavir/Ritonavir (LPV/r)	SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
21-day Lopinavir/Ritonavir (LPV/r)	SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r

Measured Values

	7-day Lamivudine/Zidovudine (3TC/ZDV)	21-day Lamivudine/Zidovudine (3TC/ZDV)	7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	7-day Lopinavir/Ritonavir (LPV/r)	21-day Lopinavir/Ritonavir (LPV/r)
Number of Participants Analyzed [units: participants]	73	67	71	65	71	65
Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping. [units: participants]	0	0	0	0	0	0

No statistical analysis provided for Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping.

4. 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 [ Time Frame: From first day of study treatment to week 12 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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
Time Frame	From first day of study treatment to week 12
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
7-day Lamivudine/Zidovudine (3TC/ZDV)	SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
21-day Lamivudine/Zidovudine (3TC/ZDV)	SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
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.
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.
7-day Lopinavir/Ritonavir (LPV/r)	SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
21-day Lopinavir/Ritonavir (LPV/r)	SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r

Measured Values

	7-day Lamivudine/Zidovudine (3TC/ZDV)	21-day Lamivudine/Zidovudine (3TC/ZDV)	7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	7-day Lopinavir/Ritonavir (LPV/r)	21-day Lopinavir/Ritonavir (LPV/r)
Number of Participants Analyzed [units: participants]	73	68	75	67	71	68
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 [units: participants]	5	1	1	0	2	2

No statistical analysis provided for 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

5. Secondary:

Number of Participants Who Discontinued Study Treatment Prematurely [ Time Frame: From first day of study treatment to last day of study treatment (up to 21 days) ]

Measure Type	Secondary
Measure Title	Number of Participants Who Discontinued Study Treatment Prematurely
Measure Description	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.
Time Frame	From first day of study treatment to last day of study treatment (up to 21 days)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
7-day Lamivudine/Zidovudine (3TC/ZDV)	SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
21-day Lamivudine/Zidovudine (3TC/ZDV)	SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
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.
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.
7-day Lopinavir/Ritonavir (LPV/r)	SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
21-day Lopinavir/Ritonavir (LPV/r)	SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r

Measured Values

	7-day Lamivudine/Zidovudine (3TC/ZDV)	21-day Lamivudine/Zidovudine (3TC/ZDV)	7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	7-day Lopinavir/Ritonavir (LPV/r)	21-day Lopinavir/Ritonavir (LPV/r)
Number of Participants Analyzed [units: participants]	73	68	75	67	71	63
Number of Participants Who Discontinued Study Treatment Prematurely [units: participants]	0	2	0	0	0	5

No statistical analysis provided for Number of Participants Who Discontinued Study Treatment Prematurely

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Clinicaltrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
phone: (617) 432-2829
e-mail: CBAR.ClinicalTrials.gov@sdac.harvard.edu

Publications:

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.

Eshleman SH, Jackson JB. Nevirapine resistance after single dose prophylaxis. AIDS Rev. 2002 Apr-Jun;4(2):59-63. Review.

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. Epub 2004 Jul 09.

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.

Sullivan JL. Prevention of mother-to-child transmission of HIV--what next? J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S67-72. Review.

Publications automatically indexed to this study:

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.

Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00099632 History of Changes
Other Study ID Numbers:	A5207, 10127, ACTG A5207, MOMS
Study First Received:	December 17, 2004
Results First Received:	December 6, 2011
Last Updated:	May 17, 2012
Health Authority:	United States: Food and Drug Administration United States: Data and Safety Monitoring Board

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