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

NCT00442962 | Completed Phase 4 Results DMC

• 2 other identifiers: ACTG A52271U01AI068636
• Study Type: interventional
• Target: 54
• Locations: 3 countries
• Sites: 9

Brief Summary

The purpose of this study is to determine if pregnancy-limited, short-term combination HIV treatment regimens -- which were used solely for the prevention of mother to child transmission of HIV and discontinued postpartum -- decreases the effectiveness of a standard initial regimen of anti-HIV drugs when subsequent treatment is needed.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Early Virologic Response

  Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml

  At Week 24

Secondary Outcomes (10)

• Time to First Safety Event

  Throughout study

• Percentage of Participants With Early Virologic Suppression

  At Weeks 24

• Percentage of Participants With Late Virologic Response

  At Week 48

• Time to Initial Virologic Response

  Throughout study

• Time to Initial Virological Failure

  Throughout study

Study Arms (1)

EFV + FTC/TDF

EXPERIMENTAL

Participants will efavirenz (600mg in pill form, taken orally, once daily) and emtricitabine/tenofovir disoproxil fumarate (200/300mg in pill form, taken orally, once daily), for 48 weeks

Drug: Efavirenz; Drug: Emtricitabine/Tenofovir disoproxil fumarate

Interventions

Efavirenz DRUG

600-mg tablet taken orally daily

Also known as: EFV

EFV + FTC/TDF

Emtricitabine/Tenofovir disoproxil fumarate DRUG

200-mg emtricitabine/300-mg tenofovir disoproxil fumarate tablet taken orally once daily

Also known as: Truvada

EFV + FTC/TDF

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 previous 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

You may not qualify if:

• 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 (version 1.0)
• Evidence of certain HIV-1 RT mutations identified by standard bulk viral population genotypic resistance tests at any time prior to study entry, if available (version 2.0, 09/03/2009)
• 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 certain antihistamines, certain anti-infectives, cisapride, St John's wort, midazolam, triazolam, dihydroergotamine, ergonovine, ergotamine, or methylergonovine within 14 days prior to study entry
• 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

Sponsors & Collaborators

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (9)

Ucsd, Avrc

San Diego, California, 92103, United States

Location

Brigham and Women's Hospital, Division of Infectious Disease

Boston, Massachusetts, 02115, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Weill Med. College of Cornell Univ., The Cornell CTU -Chelsea

New York, New York, 10011, United States

Location

Bronx-Lebanon Hosp. Ctr. CRS

The Bronx, New York, 10457, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz

Rio de Janeiro, 21045, Brazil

Location

San Miguel CRS

San Miguel, Lima region, Peru

Location

Barranco CRS

Lima, 18, Peru

Location

Related Publications (3)

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

  PMID: 15595430 BACKGROUND

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

  PMID: 15000589 BACKGROUND

• 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. doi: 10.1097/QAD.0b013e328011770b.

  PMID: 17197811 BACKGROUND

Related Links

• Click here for more information on this network of studies

MeSH Terms

Conditions

HIV Infections

Interventions

efavirenz; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: ACTG ClinicalTrials.gov Coordinator
• Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.

ACTGCT.Gov@s-3.com

(301) 628-3313

Study Officials

• Mary A. Vogler, MD

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 5, 2007
• Study Start: May 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 12, 2018
• Results First Posted: August 9, 2011

Record last verified: 2018-09

Locations

PE (2); US (6); BR (1)