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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

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 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

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

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

Click here for more information on this network of studies

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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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