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A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-Risk Populations in Kenya, Africa

5. august 2010 oppdatert av: International AIDS Vaccine Initiative

A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-risk Populations in Kenya, Africa

This study will evaluate the safety and acceptability of an intermittent and daily PrEP regimen using Tenofovir Disoproxil Fumarate plus Emtricitabine (FTC/TDF) in men and women at risk for HIV, and it will directly compare adherence and intracellular drug levels in daily and intermittent PrEP recipients. It will also evaluate the relationship between drug adherence, sexual behavior and intracellular drug levels with an intermittent PrEP regimen. In addition it will evaluate the relationship between adherence to an intermittent PrEP regimen and timing of sexual activity in relation to PrEP dosing. The study will use objective medication event monitoring medication event monitors (MEMS) adherence measurement and evaluate the feasibility of newer adherence measurements such as hair sampling and plasma drug levels. The study will also evaluate the feasibility of using SMS (text messages) to collect sexual activity data in an African setting. It will allow study teams and communities to prepare for potential subsequent larger trials of intermittent PrEP. This study is not sized to evaluate efficacy. If the intermittent PrEP regimen is shown to be safe, feasible in terms of adherence, and achieves intracellular drug levels similar to daily PrEP, these data could be used to design a larger phase 2 study with one or more intermittent PrEP regimens. The goal of such a trial would be to provide bridging data if daily PrEP regimens are found to be effective or to prepare for efficacy or non-inferiority trials of intermittent versus daily PrEP.

Investigation of immune responses associated with FTC/TDF will also be evaluated in the pilot study. The proportion of volunteers on FTC/TDF with HIV-specific immune responses, due to exposures that did not lead to established HIV infection, will be assessed at 2-3 time points and compared to responses in volunteers assigned to placebo. Immune responses may be correlated with risk behavior and host factors, such as human leukocyte antigen (HLA) type. As noted above, very few HIV infections are expected to occur during the study, so correlation of HIV-specific immune responses and protection from infection or attenuation of disease progression will not be possible until a larger study is conducted.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

72

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kenya
      • Kilifi, Kenya
        • Kenya Medical Research Institute, Center for Geographic Medicine Research - Coast
      • Nairobi, Kenya
        • Kenya AIDS Vaccine Initiative, University of Nairobi

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 49 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria

  • Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
  • Has understood the information provided and has provided written informed consent before any study-related procedures are performed
  • Willing to undergo HIV testing, STI screening, HIV counselling and receive HIV and STI test results

  • At risk for HIV infection as defined by at least one of the following:

    • Current sexually-transmitted infection (STI) or STI in the previous 3 months
    • In the past 3 months had multiple episodes of unprotected vaginal sex
    • In the past 3 months had multiple episodes of unprotected anal sex
    • In the past 3 months engaged in sex work for money or drugs
  • If a female of childbearing potential (i.e., not post-menopausal or surgically sterile), using an effective method of non-barrier contraception (hormonal contraceptive; intrauterine device (IUD); surgical sterility) from 7 days prior to randomization until the end of the study. All female volunteers must be willing to undergo urine pregnancy tests

Exclusion Criteria

  • Confirmed HIV-1 or HIV-2 infection
  • Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator would make the volunteer unsuitable for the study, including severe infections requiring treatment such as tuberculosis, and alcohol or drug abuse

  • Any of the following abnormal laboratory parameters:

    • Haemoglobin <9.0 g/dL
    • Creatinine clearance <80mL/min, as calculated by Cockcroft-Gault equation
    • AST: >2.5 x ULN
    • ALT: >2.5 x ULN
    • Total bilirubin >1.5 x ULN
    • Serum amylase >1.5 x ULN
    • Serum phosphorus <2.4 mg/dL

    • Urinalysis: Two abnormal dipsticks showing any of the following:

      • blood = 2+ or more (not due to menses)
      • protein = 1+ or more
      • leucocytes = 2+ or more
      • glucose= 1+ or more
  • Confirmed diagnosis of chronic hepatitis B infection (HBsAg positive)
  • If female, pregnant or planning a pregnancy within 4 months after enrolment or lactating
  • Participation in another clinical study of an investigational product currently, within the 3 months prior to enrolment or expected participation during this study

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: FTC/TDF- Daily
FTC/TDF dosed daily
Legemiddel: FTC/TDF
emtricitabine/tenofovir disoproxil fumarate
Eksperimentell: FTC/TDF-Intermittent
FTC/TDF dosed intermittently
Legemiddel: FTC/TDF
emtricitabine/tenofovir disoproxil fumarate
Placebo komparator: Placebo-Daily
Placebo dosed daily
Legemiddel: Placebo
Placebo
Placebo komparator: Placebo-Intermittent
Placebo dosed intermittently
Legemiddel: Placebo
Placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Safety and tolerability: The proportion of volunteers with moderate and greater severity clinical adverse events; mild, moderate and greater severity of renal toxicities, and other moderate and severe laboratory abnormalities.
Tidsramme: 6 months
6 months
Acceptability: The proportion of volunteers who report willingness to use the study regimen
Tidsramme: 6 months
6 months
Intracellular drug concentrations: The mean intracellular drug concentration for each group assigned to FTC/TDF
Tidsramme: 6 months
6 months
Adherence: Proportion of volunteers who took, by MEMS data, at least 80% of expected doses of the IP; Proportion of volunteers assigned to FTC/TDF who have detectable drug plasma levels within 48 hrs of use.
Tidsramme: 6 months
6 months
Behavioral: Reported number of steady and casual sex partners; Frequency of unprotected vaginal and/or anal intercourse; Substance use prior to or during sex
Tidsramme: 6 months
6 months

Sekundære resultatmål

Resultatmål
Tidsramme
Proportion of volunteers who report somewhat high or high levels of burden in using electronic medication monitoring to measure adherence, and using cell phone communication to measure sexual activity
Tidsramme: 6 months
6 months
The proportion of study days with missing SMS sexual activity data
Tidsramme: 6 months
6 months
The proportion of volunteers who report sharing medications
Tidsramme: 6 months
6 months
The proportion of volunteers assigned to placebo who have detectable intracellular drug levels
Tidsramme: 6 months
6 months
The proportion of volunteers with HIV-specific immune responses as measured by analysis of cellular or humoral immune response, or changes in gene regulation as measured by microarray or proteomic techniques
Tidsramme: 6 months
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

International AIDS Vaccine Initiative

Etterforskere

  • Hovedetterforsker: Gaudensia Mutua, MB.ChB, MPH, Kenya AIDS Vaccine Initiative, University of Nairobi
  • Hovedetterforsker: E.J. Sanders, MD, MPH, PhD, Kenya Medical Research Institute, Center for Geographic Medicine Research - Coast
  • Studiestol: Omu Anzala, MB.ChB, Phd, Kenya AIDS Vaccine Initiative, University of Nairobi

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2009

Primær fullføring (Faktiske)

1. juni 2010

Studiet fullført (Faktiske)

1. juli 2010

Datoer for studieregistrering

Først innsendt

2. september 2009

Først innsendt som oppfylte QC-kriteriene

2. september 2009

Først lagt ut (Anslag)

3. september 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. august 2010

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. august 2010

Sist bekreftet

1. august 2010

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IAVI E001

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