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HIV InfectionsPhase 4Nearly NaiveNCT00442962

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

A Phase 4 study testing Efavirenz and Emtricitabine/Tenofovir disoproxil fumarate in people with HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 9 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 16 years and older, women only
Conditions the study is for
HIV Infections
What is being tested?
Efavirenz and Emtricitabine/Tenofovir disoproxil fumarate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
9 sitesin 3 countries
Study dates
May 2007to Dec 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

9 sites in 3 countries.

9 sites in 3 countries

United States6 sites

  • Brigham and Women's Hospital, Division of Infectious Disease

    Boston, Massachusetts, 02115

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

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

    New York, New York, 10011

  • Ucsd, Avrc

    San Diego, California, 92103

  • Washington University School of Medicine

    St Louis, Missouri, 63108

  • Bronx-Lebanon Hosp. Ctr. CRS

    The Bronx, New York, 10457

Other trials in United States

Peru2 sites

  • Barranco CRS

    Lima, 18

  • San Miguel CRS

    San Miguel, Lima region

Other trials in Peru

Brazil1 site

  • Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz

    Rio de Janeiro, 21045

Other trials in Brazil

About this 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

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.

Read the 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.

Conditions
HIV Infections
Being tested
Efavirenz, Emtricitabine/Tenofovir disoproxil fumarate
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EfavirenzDrug

    Also called EFV

    600-mg tablet taken orally daily

  • Emtricitabine/Tenofovir disoproxil fumarateDrug

    Also called Truvada

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

Study groups in NCT00442962
Study groupRoleWhat they receive
EFV + FTC/TDFExperimentalParticipants 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
Receives: Drug: Efavirenz; Drug: Emtricitabine/Tenofovir disoproxil fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Early Virologic Response

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

    Measured: At Week 24

Secondary outcomes (10)

  1. 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.

    Measured: Throughout study

  2. Percentage of Participants With Early Virologic Suppression

    Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml

    Measured: At Weeks 24

  3. Percentage of Participants With Late Virologic Response

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

    Measured: At Week 48

  4. Time to Initial Virologic Response

    Time from enrollment to scheduled week of first plasma HIV-1 RNA viral load fewer than 400 copies/mL.

    Measured: Throughout study

  5. 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.

    Measured: Throughout study

  6. Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm)

    Measured: Throughout study

  7. Early Changes in CD4 Count From Baseline

    Changes in CD4+ lymphocyte counts between study visit weeks 4, 8 16 and 24 and baseline.

    Measured: At weeks 0(baseline), 4, 8, 16, 24

  8. Percentage of Participants With Late Virologic Suppression

    Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml

    Measured: At Week 48

  9. Time to First Dose Modification

    Time from starting study treatment to first dose/drug modification.

    Measured: Throughout study

  10. Late Change in CD4 Count From Baseline

    Change in CD4+ lymphocyte counts between week 48 study visit and baseline.

    Measured: At week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionJul 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00442962
Sponsor's protocol ID
ACTG A5227
Other IDs
1U01AI068636
Acronym
Nearly Naive
Status last verified
Sep 2018
First submitted
2 Mar 2007
Last updated
12 Oct 2018
Data monitoring committee
Yes

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.

    PubMed 15595430

  • 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.

    PubMed 15000589

  • 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.

    PubMed 17197811

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Efavirenz and Emtricitabine/Tenofovir disoproxil fumarate in people with HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 9 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Peru, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Early Virologic Response (time frame: At Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00442962, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.

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