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Anti-HIV Medications and Structured Treatment Interruptions for People Recently Infected With HIV

26. oktober 2012 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

A Randomized, Multicenter Trial to Determine Whether Induction Therapy Followed by Treatment Interruption is Superior to Induction Therapy Alone in the Treatment of Primary HIV Infection (PHI): The Structured Treatment Interruption (STI) Study

People recently infected with HIV who are treated with anti-HIV medications may develop strong immune system responses to HIV and may be able to control the virus without continuing to take these medications. The purpose of this study is to see if giving anti-HIV medications to people soon after they have been infected with HIV can help them control HIV. The study will also see if the immune system can control the amount of HIV virus in the blood (viral load) even after a person has stopped taking the medications. The study will evaluate three different schedules of stopping and starting anti-HIV medications to see which schedule is best able to boost a patient's immune system to control HIV viral load.

Hypothesis: Combination therapy started in primary HIV infection, in conjunction with structured treatment interruptions, will result in greater control of viremia off treatment than induction therapy alone.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Initiation of treatment during acute HIV infection seems to result in greater suppression of viral replication than noted during chronic infection and better recovery of certain CD4 subpopulations. However, it is difficult for patients treated during acute infection to maintain long-term continuous antiretroviral (ARV) treatment because of difficulty adhering to complicated medication regimens, drug-related toxicities, and cost of medications. Acutely infected patients who have undergone early initiation of treatment followed by structured treatment interruptions (STIs) appear to have lower off-treatment viral loads than historical controls. This study will evaluate whether effective ARV treatment during acute and early HIV infection followed by STI will result in lower viral setpoints than would otherwise be expected.

This trial will have 2 steps and will last for a maximum of 104 weeks. Participants will either enter Step 1 and continue on to Step 2 or enter Step 2 directly. During Step 1, participants with acute or early HIV infection will be given 24 weeks of ARV therapy. Participants may take any combination of FDA-approved ARV medications that they and their doctors select. Participants will have study visits at study entry and Weeks 1, 4, 8, and 20. After 24 weeks on Step 1, participants may enroll in Step 2.

Participants in Step 1 and people with early or acute HIV infection who began ARV treatment within 21 days of diagnosis and have had no more than 1 year of treatment may enroll in Step 2. During Step 2, participants will be randomly assigned to one of two study arms:

  • Arm 1: Participants will continue taking ARV therapy for 16 weeks and then stop ARVs for 64 weeks.
  • Arm 2: Participants will stop ARVs for 4 weeks, take ARVs for 8 weeks, stop ARVs for 4 weeks, take ARVs for 8 weeks, and then stop ARVs for 56 weeks.

Participants in both study arms will restart ARVs regardless of STI duration if their viral load is above 50,000 copies/ml, they progress to CDC category C disease, or their CD4 count falls below 350 cells/mm3 or declines more than 50% from the last on-treatment CD4 level.

Step 2 will last 80 weeks. For the first year, participants will have study visits every 1 to 4 weeks, depending on whether they are taking ARVs. During the second year, participants will have study visits every 8 weeks. Study visits will include a brief medical history, blood and pregnancy tests, and voluntary behavioral questionnaires.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Note: Step 2, Arm 3 has been eliminated as of 12/13/04.

Inclusion Criteria for Step 1:

  • Acute or early HIV infection as defined by the study
  • Agrees to use acceptable methods of contraception
  • Agrees to begin antiretroviral treatment regimen within 21 days of diagnosis and no more than 3 days after study entry

Exclusion Criteria for Step 1:

  • Unwilling to follow random assignment in Step 2
  • Abnormal laboratory result within 21 days prior to study entry, unless abnormality is considered part of acute HIV infection
  • Have taken antiretroviral drugs other than for postexposure prophylaxis (PEP). Patients who have undergone up to 30 days of previous PEP treatment are not excluded.
  • Pregnancy or breastfeeding
  • Previous participation in an HIV vaccine trial
  • Previous use of experimental therapeutic immunizations or cytokine infusions

Inclusion Criteria for Participants Enrolling Directly into Step 2:

  • Viral load of less than 400 copies/ml
  • Enrolled in the AIEDRP CORE01 study, with stored blood samples obtained within 21 days prior to starting treatment on CORE01
  • Currently receiving antiretroviral treatment regimen, with no interruptions for more than 7 consecutive days since the beginning of treatment
  • Antiretroviral treatment was started within 21 days after HIV diagnosis
  • Agrees to use acceptable methods of contraception

Exclusion Criteria for Step 2:

  • Unwilling to follow random assignment to study arms and follow scheduled treatment interruptions
  • More than 52 weeks of ARV treatment since diagnosis of acute/early HIV infection prior to entering Step 2
  • CD4 count less than 350 cells/mm3 within 28 days of entry into Step 2
  • AIDS-defining illness
  • Pregnant or breastfeeding
  • Previous participation in an HIV vaccine trial
  • Previous use of experimental therapeutic immunizations or cytokine infusions

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
In Step 1, participants will receive ARV therapy for 24 weeks. Upon entering Step 2, participants will continue taking ARV therapy for 16 weeks and then stop ARVs for 64 weeks.
Adfærdsmæssigt: Structured treatment interruption
Treatment interruption schedule is dependent on the Arm in which participants are enrolled in Step 2
Medicin: Antiretroviral regimen
Participants will take any combination of FDA-approved ARV medications prescribed by their physician
Eksperimentel: 2
In Step 1, participants will receive ARV therapy for 24 weeks. Upon entering Step 2, participants will stop ARVs for 4 weeks, take ARVs for 8 weeks, stop ARVs for 4 weeks, take ARVs for 8 weeks, and then stop ARVs for 56 weeks.
Adfærdsmæssigt: Structured treatment interruption
Treatment interruption schedule is dependent on the Arm in which participants are enrolled in Step 2
Medicin: Antiretroviral regimen
Participants will take any combination of FDA-approved ARV medications prescribed by their physician

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Difference in mean HIV viral load between arms
Tidsramme: At Week 80
At Week 80

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Efterforskere

  • Studiestol: Eric Rosenberg, MD, Massachusetts General Hospital
  • Studiestol: Don Smith, MB, ChB, MD, University of New South Wales, Australia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Datoer for studieregistrering

Først indsendt

4. juni 2004

Først indsendt, der opfyldte QC-kriterier

4. juni 2004

Først opslået (Skøn)

7. juni 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. oktober 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. oktober 2012

Sidst verificeret

1. oktober 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AIEDRP AIN502

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-infektioner

Kliniske forsøg med Structured treatment interruption

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Togo

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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