HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV (Nearly Naive)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Efavirenz
Emtricitabine/Tenofovir disoproxil fumarate
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility 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 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
Sites / Locations
- Ucsd, Avrc
- Brigham and Women's Hospital, Division of Infectious Disease
- Washington University School of Medicine
- Bronx-Lebanon Hosp. Ctr. CRS
- Weill Med. College of Cornell Univ., The Cornell CTU -Chelsea
- University of North Carolina
- Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz
- San Miguel CRS
- Barranco CRS
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EFV + FTC/TDF
Arm Description
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
Outcomes
Primary Outcome Measures
Percentage of Participants With Early Virologic Response
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml
Secondary Outcome Measures
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.
Percentage of Participants With Early Virologic Suppression
Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml
Percentage of Participants With Late Virologic Response
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml
Time to Initial Virologic Response
Time from enrollment to scheduled week of first plasma HIV-1 RNA viral load fewer than 400 copies/mL.
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.
Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm)
Early Changes in CD4 Count From Baseline
Changes in CD4+ lymphocyte counts between study visit weeks 4, 8 16 and 24 and baseline.
Percentage of Participants With Late Virologic Suppression
Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml
Time to First Dose Modification
Time from starting study treatment to first dose/drug modification.
Late Change in CD4 Count From Baseline
Change in CD4+ lymphocyte counts between week 48 study visit and baseline.
Full Information
NCT ID
NCT00442962
First Posted
March 2, 2007
Last Updated
September 11, 2018
Sponsor
AIDS Clinical Trials Group
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00442962
Brief Title
HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AIDS Clinical Trials Group
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.> >>
>
>> 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.>
>>
>
>> Enrollment in this study will last until 47 participants have joined or until December 31, 2009, whichever comes later.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EFV + FTC/TDF
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Other Intervention Name(s)
EFV
Intervention Description
600-mg tablet taken orally daily
Intervention Type
Drug
Intervention Name(s)
Emtricitabine/Tenofovir disoproxil fumarate
Other Intervention Name(s)
Truvada
Intervention Description
200-mg emtricitabine/300-mg tenofovir disoproxil fumarate tablet taken orally once daily
Primary Outcome Measure Information:
Title
Percentage of Participants With Early Virologic Response
Description
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml
Time Frame
At Week 24
Secondary Outcome Measure Information:
Title
Time to First Safety Event
Description
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.
Time Frame
Throughout study
Title
Percentage of Participants With Early Virologic Suppression
Description
Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml
Time Frame
At Weeks 24
Title
Percentage of Participants With Late Virologic Response
Description
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml
Time Frame
At Week 48
Title
Time to Initial Virologic Response
Description
Time from enrollment to scheduled week of first plasma HIV-1 RNA viral load fewer than 400 copies/mL.
Time Frame
Throughout study
Title
Time to Initial Virological Failure
Description
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.
Time Frame
Throughout study
Title
Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm)
Time Frame
Throughout study
Title
Early Changes in CD4 Count From Baseline
Description
Changes in CD4+ lymphocyte counts between study visit weeks 4, 8 16 and 24 and baseline.
Time Frame
At weeks 0(baseline), 4, 8, 16, 24
Title
Percentage of Participants With Late Virologic Suppression
Description
Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml
Time Frame
At Week 48
Title
Time to First Dose Modification
Description
Time from starting study treatment to first dose/drug modification.
Time Frame
Throughout study
Title
Late Change in CD4 Count From Baseline
Description
Change in CD4+ lymphocyte counts between week 48 study visit and baseline.
Time Frame
At week 48
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary A. Vogler, MD
Organizational Affiliation
Division of Infectious Diseases, Weill College of Medicine of Cornell University
Official's Role
Study Chair
Facility Information:
Facility Name
Ucsd, Avrc
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Brigham and Women's Hospital, Division of Infectious Disease
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Bronx-Lebanon Hosp. Ctr. CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Weill Med. College of Cornell Univ., The Cornell CTU -Chelsea
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz
City
Rio de Janeiro
ZIP/Postal Code
21045
Country
Brazil
Facility Name
San Miguel CRS
City
San Miguel
State/Province
Lima
Country
Peru
Facility Name
Barranco CRS
City
Lima
ZIP/Postal Code
18
Country
Peru
12. IPD Sharing Statement
Citations:
PubMed Identifier
15595430
Citation
Abrams EJ. Prevention of mother-to-child transmission of HIV--successes, controversies and critical questions. AIDS Rev. 2004 Jul-Sep;6(3):131-43.
Results Reference
background
PubMed Identifier
15000589
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.
Results Reference
background
PubMed Identifier
17197811
Citation
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.
Results Reference
background
Links:
URL
http://www.actgnetwork.org
Description
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HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV
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