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

HIV Infections Clinical Trial

— Nearly Naive  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00442962
• Other study ID #: ACTG A5227
• Secondary ID: 1U01AI068636
• Status: Completed
• Phase: Phase 4
• Start date: May 2007
• Est. completion date: December 2010

Study information

• Verified date: September 2018
• Source: AIDS Clinical Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Stopping and restarting highly active antiretroviral therapy (HAART) is not generally recommended because it has the potential to allow drug-resistant HIV to emerge. 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 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.

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> Study follow-up will last for 48 weeks per participant. Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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 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

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 (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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Efavirenz
600-mg tablet taken orally daily
• Emtricitabine/Tenofovir disoproxil fumarate
200-mg emtricitabine/300-mg tenofovir disoproxil fumarate tablet taken orally once daily

Locations

Country	Name	City	State
Brazil	Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz	Rio de Janeiro
Peru	Barranco CRS	Lima
Peru	San Miguel CRS	San Miguel	Lima
United States	Brigham and Women's Hospital, Division of Infectious Disease	Boston	Massachusetts
United States	Bronx-Lebanon Hosp. Ctr. CRS	Bronx	New York
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Weill Med. College of Cornell Univ., The Cornell CTU -Chelsea	New York	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Ucsd, Avrc	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
AIDS Clinical Trials Group	National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Brazil,  Peru, 

References & 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. Review. — View Citation

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. Review. — View Citation

Duran AS, Losso MH, Salomón 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Early Virologic Response	Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml	At Week 24
Secondary	Time to First Safety Event	Time from starting study treatment to first grade 3 or 4 sign/symptom or laboratory abnormality and at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.	Throughout study
Secondary	Percentage of Participants With Early Virologic Suppression	Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml	At Weeks 24
Secondary	Percentage of Participants With Late Virologic Response	Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml	At Week 48
Secondary	Time to Initial Virologic Response	Time from enrollment to scheduled week of first plasma HIV-1 RNA viral load fewer than 400 copies/mL.	Throughout study
Secondary	Time to Initial Virological Failure	Virologic failure defined as two consecutive measurements of plasma HIV-1 RNA at least 400 copies/mL at or after the week 16 study visit. Time measured from enrollment.	Throughout study
Secondary	Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm)		Throughout study
Secondary	Early Changes in CD4 Count From Baseline	Changes in CD4+ lymphocyte counts between study visit weeks 4, 8 16 and 24 and baseline.	At weeks 0(baseline), 4, 8, 16, 24
Secondary	Percentage of Participants With Late Virologic Suppression	Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml	At Week 48
Secondary	Time to First Dose Modification	Time from starting study treatment to first dose/drug modification.	Throughout study
Secondary	Late Change in CD4 Count From Baseline	Change in CD4+ lymphocyte counts between week 48 study visit and baseline.	At week 48

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