HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00442962

Purpose

To prevent the mother-to-child transmission (MTCT) of HIV, pregnant women are temporarily put on anti-HIV drugs even though their infection may not require treatment. The purpose of this study is to determine if short-term HIV treatment during pregnancy decreases the effectiveness of the standard initial regimen of anti-HIV drugs once treatment is needed.

Condition	Intervention
HIV Infections	Drug: Efavirenz Drug: Emtricitabine/Tenofovir disoproxil fumarate

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	The Effect of Prior Short Course Combination Antiretroviral Therapy Administered for the Prevention of Mother-to-Child Transmission (pMTCT) of HIV-1 on Subsequent Treatment Efficacy in Treatment-"Nearly Naive" Participants

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Tenofovir Efavirenz Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Virologic response [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of efavirenz (EFV) and emtricitabine/tenofovir disproxil fumarate (FTC/TDF) regimen [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Virologic suppression [ Time Frame: At Weeks 24 and 48 ] [ Designated as safety issue: No ]
Virologic response [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
Time to initial virologic response and suppression [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Time to initial virological failure [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Time to loss of virological response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Presence of drug-resistant minority variants [ Time Frame: At study entry ] [ Designated as safety issue: No ]
Plasma concentrations of EFV, FTC, and TDF [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Changes in CD4 count [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Adherence to drug regimen [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Quality-of-life score [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	47
Study Start Date:	May 2007
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disproxil fumarate for 48 weeks	Drug: Efavirenz 600-mg tablet taken orally daily Drug: Emtricitabine/Tenofovir disoproxil fumarate 200-mg emtricitabine/300-mg tenofovir disoproxil fumarate tablet taken orally once daily

Detailed Description:

Stopping and restarting highly active antiretroviral therapy (HAART) is not recommended because it has the potential to allow drug-resistant HIV to take over the viral population. However, to prevent mother-to-child transmission (MTCT), HIV infected women who are pregnant are temporarily put on HAART, even if HIV treatment is not indicated at the time. It is unknown, however, if such short-term therapy affects the viral response to HAART later, when permanent therapy is clinically indicated. The purpose of this study is to determine if HAART taken to prevent MTCT during pregnancy has an effect on the ability of a standard initial regimen of HAART to suppress HIV viral load.

This study will last for 48 weeks. Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disproxil fumarate. There will be 8 clinical visits in this study; visits will occur at baseline and at Weeks 2, 4, 8, 16, 24, 36, and 48. At each visit, a physical exam, blood and urine collection, and pregnancy tests will occur. At some visits, adherence, quality-of-life, and birth control interviews will be completed.

Enrollment in this study will last until 47 participants have joined or until December 31, 2009, whichever comes later.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV-1 infected
Viral load of 500 copies/mL or more
Prior HAART for more than 7 days, but less than 40 weeks during at least one pregnancy for prevention of MTCT of HIV
Clinical or laboratory indication to start HAART, in the opinion of the participant's physician
Certain laboratory values
Willingness to use acceptable forms of contraception
Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

Taking any antiretroviral medication within 24 weeks prior to study entry
Evidence of certain HIV-1 RT mutations within 90 days prior to study entry
Evidence of certain HIV-1 mutations identified by standard bulk viral population genotypic resistance tests at any time prior to study entry, if available
Treatment at any time, for any reason with nevirapine as a single agent OR addition of any part of the study regimen as a single agent to a failing regimen
Use of antihistamines, anti-infectives, cisapride, St John's wort, midazolam, triazolam, dihydroergotamine, ergonovine, ergotamine, or methylergonovine within 14 days prior to study entry
Require certain medications during the study
Use of HIV vaccine, chronic systemic corticosteroids, interleukins, interferons, other cytokines, or investigational therapy within 30 days prior to study entry
Acute or chronic therapy for certain serious medical illnesses within 14 days of study entry. Participants who have completed 7 days of therapy and are judged clinically stable are not excluded.
Cancer requiring systemic chemotherapy
Known allergy/sensitivity to the study drugs or their formulations
Current drug or alcohol use that, in the opinion of the investigator, would interfere with the study
Two consecutive HIV viral loads of more than 5,000 copies/mL 8 weeks or more following initiation of HAART during pregnancy and while still receiving HAART
Two consecutive viral loads of more than 400 copies/mL 24 weeks or more following initiation of HAART during pregnancy while still receiving HAART
Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical illness
Pregnancy or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442962

Locations

United States, California
UCSD, AVRC	Recruiting
San Diego, California, United States, 92103
Contact: Jill Kunkel, RN 619-543-8080 jkunkel@ucsd.edu
Principal Investigator: Constance A. Benson, MD
United States, Massachusetts
Brigham and Women's Hospital, Division of Infectious Disease	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jon Gothing, RN, BSN, ACRN 617-732-5635 jgothing@partners.org
Principal Investigator: Paul Edward Sax, MD
United States, Missouri
Washington University School of Medicine	Active, not recruiting
St. Louis, Missouri, United States, 63108
United States, New York
Weill Med. College of Cornell Univ., The Cornell CTU -Chelsea	Recruiting
New York, New York, United States, 10011
Contact: Todd Stroberg, RN 212-746-7198 tstrober@nyp.org
Principal Investigator: Marshall J. Glesby, MD
United States, North Carolina
University of North Carolina	Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Cheryl J. Marcus, RN, BSN 919-843-8761 cjm@med.unc.edu
Principal Investigator: Joseph J. Eron, MD
Moses H. Cone Memorial Hosp., Internal Medicine Training Program	Recruiting
Greensboro, North Carolina, United States, 27401
Contact: Kim Epperson, RN 336-832-7888 kim.epperson@mosescone.com
Principal Investigator: Timothy W. Lane, MD
Brazil
Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz	Recruiting
Rio de Janero, Brazil, 21045
Contact: Sandra Wagner Cardoso (552) 125 644933 sandra.wagner@bol.com.br
Principal Investigator: Beatriz Grinsztejn, MD, PhD
Puerto Rico
Puerto Rico/Pediatric Hospital	Not yet recruiting
San Juan, Puerto Rico, 00936
Contact: Karen G. Savage, BSN 205-975-7925 kgsavage@uab.edu
Principal Investigator: Michael Saag, MD

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:

Mary A. Vogler, MD

Division of International Medicine and Infectious Diseases, Weill College of Medicine of Cornell University

More Information

Additional Information:

Click here for more information about efavirenz This link exits the ClinicalTrials.gov site

Click here for more information about emtricitabine/tenofovir disproxil fumarate This link exits the ClinicalTrials.gov site

Click here for more information about medication for HIV positive pregnant women This link exits the ClinicalTrials.gov site

Haga clic aquí para ver información sobre este ensayo clínico en español This link exits the ClinicalTrials.gov site

Click here for more information on this network of studies This link exits the ClinicalTrials.gov site

Publications:

Abrams EJ. Prevention of mother-to-child transmission of HIV--successes, controversies and critical questions. AIDS Rev. 2004 Jul-Sep;6(3):131-43.

Bassetti D, Cargnel A. Genotypic resistance tests for the management of the HIV-infected pregnant woman. Scand J Infect Dis Suppl. 2003 Dec;35 Suppl 106:70-4. Review.

Duran AS, Losso MH, Salomon H, Harris DR, Pampuro S, Soto-Ramirez LE, Duarte G, de Souza RS, Read JS; NISDI Perinatal Study Group. Drug resistance among HIV-infected pregnant women receiving antiretrovirals for prophylaxis. AIDS. 2007 Jan 11;21(2):199-205.

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	ACTG A5227
Study First Received:	March 2, 2007
Last Updated:	November 5, 2009
ClinicalTrials.gov Identifier:	NCT00442962 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Emtricitabine
Anti-Retroviral Agents
Therapeutic Uses
Tenofovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil

Efavirenz
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on February 08, 2010