- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03877536
Antiretroviral Therapy for Acute HIV Infection
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Kampala, Uganda
- Makerere University--Walter Reed Project (MUWRP)
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- First identified as an incident HIV infection within one year of estimated time of infection in RV 217.
- Willing to begin Genvoya® as soon as entering this study but not later than 7 days from study enrollment.
- Successfully passed Test of Understanding (TOU) with a score of 80% or more on ten questions after three attempts.
- Adult from 18 to 50 years of age.
- Able to participate for 96 weeks of study visits
- In general good health as determined by the PI or his/her designee
- Willing to have photo or fingerprint taken for identification purposes
- No history of ART for any reason, i.e., treatment naïve and no HIV-post-exposure prophylaxis (PEP) or HIV-pre-exposure prophylaxis (PrEP)) within 90 days prior to enrollment
- Willing to have blood samples collected and stored.
- Adequate renal function: estimated creatine clearance of >50 mL/min according to the Cockroft Gault formula 2 weeks prior to enrollment
- Urine clean catch: glucose < trace and protein <1+ or as per site-specification 2 weeks prior to enrollment
- Weight is > 35 kg
- Female (only women of childbearing potential) Specific Criteria:
Negative pregnancy test 48 hours prior to enrollment:
Commits to continued use of adequate birth control method for 96 weeks of the study and prior to receiving study ART. Adequate birth control is defined as follows: Contraceptive medications delivered orally, intramuscularly, vaginally, or implanted, underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms, diaphragms, intrauterine device (IUD), or abstinence. If depending on hormonal contraception, check package insert for drug interactions and/or consider adding a second barrier method.
Exclusion Criteria:
- Any chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer, including but not limited to chronic hepatitis, renal insufficiency or failure; clinically significant forms of drug or alcohol abuse, mental illness, severe asthma, psychiatric disorders, heart disease, or cancer; or a physical finding on examination considered indicative of significant disease such as murmur (other than functional), hepatosplenomegaly, focal neurological deficit, etc.
- Untreated AIDS-related opportunistic infection
- An AIDS defining condition diagnosed within 30 days
- Positive Hepatitis B surface antigen at any time in the past
- Requiring use of any medication that is contraindicated with Genvoya®. See Appendix I and the package insert
- Women who are breast-feeding
There are no inclusion/exclusion criteria based on CD4 count because CD4 count can be transiently diminished during acute HIV infection and ART initiation during early or acute HIV infection offers the potential benefit of limiting reservoir seeding and preventing immune destruction regardless of peripheral CD4 count at the time of treatment initiation.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Genvoya 150Mg-150Mg-200Mg-10Mg Tablet
Genvoya® (Elvitegravir, corbiscistat, Emtricitabine and Tenofovir Alafenamide): once a day antiretroviral pill starting within 1 week of enrollment.
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Participants will receive 1 tablet per day throughout study duration (96 weeks).
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Plasma viral load
Zeitfenster: Measured at 48 weeks after enrollment
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The number of study participants with plasma viral load <50 copies/mL
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Measured at 48 weeks after enrollment
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Plasma viral load
Zeitfenster: Measured at 96 weeks after enrollment
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The number of study participants with plasma viral load <50 copies/mL
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Measured at 96 weeks after enrollment
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Drug-related AEs and SAEs
Zeitfenster: Measured through week 96
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Occurrence of drug-related adverse events and serious adverse events at any time from enrollment up to 96 weeks after enrollment early HIV infection.
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Measured through week 96
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Treatment Discontinuation for AEs up to 96 weeks
Zeitfenster: Measured through week 96
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Tolerability of treatment as measured by treatment discontinuation for AEs up to 96 weeks
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Measured through week 96
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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CD4+ T cell count change
Zeitfenster: Measured over 48 weeks
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CD4+ T cell count change over first 48 weeks as compared to baseline.following
the initiation of Genvoya®
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Measured over 48 weeks
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Frequency of HIV-related illnesses
Zeitfenster: Measured through week 96
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Frequency of HIV-related illnesses (including acute retroviral syndrome)
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Measured through week 96
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Duration of HIV-related illnesses
Zeitfenster: Measured through week 96
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Duration of HIV-related illnesses (including acute retroviral syndrome)
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Measured through week 96
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Changes in HIV-specific immune responses over time
Zeitfenster: Measured through week 96
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Description of changes in HIV-specific immune responses over time as characterized by intracellular cytokine staining (ICS)
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Measured through week 96
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Host humoral (IgG) responses
Zeitfenster: Measured through week 96
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Characterization of evolution in host humoral (IgG) responses to HIV envelope over time including development of neutralizing antibody responses
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Measured through week 96
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Markers of Immune Activation
Zeitfenster: Measured through week 96
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Description of markers of immune activation (soluble and cellular markers) by ICS.
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Measured through week 96
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HIV reservoir size
Zeitfenster: Measured through week 96
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Evaluation of the HIV reservoir size by measurement of 1) single copy HIV RNA quantification in samples with HIV RNA <50 copies/mL and 2) total HIV DNA and integrated HIV DNA in peripheral blood
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Measured through week 96
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Neuropsychological battery performance
Zeitfenster: Measured through week 96
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Evaluation of neuropsychological battery performance at week 48 and 96; and to later compare to RV 217 data from pre-infection and baseline early or acute HIV infection timepoints.
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Measured through week 96
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienstuhl: Christina Polyak, MD, MPH, Henry M. Jackson Foundation in support of MHRP
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Voraussichtlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- RNA-Virusinfektionen
- Viruserkrankungen
- Durch Blut übertragene Infektionen
- Sexuell übertragbare Krankheiten, viral
- Sexuell übertragbare Krankheiten
- Lentivirus-Infektionen
- Retroviridae-Infektionen
- Immunologische Mangelsyndrome
- Erkrankungen des Immunsystems
- Krankheitsattribute
- Langsame Viruserkrankungen
- HIV-Infektionen
- Infektionen
- Übertragbare Krankheiten
- Erworbenes Immunschwächesyndrom
- Antiinfektiva
- Antivirale Mittel
- Anti-HIV-Agenten
- Antiretrovirale Mittel
- Elvitegravir, Cobicistat, Emtricitabin, Tenofovir Disoproxil Fumarat Wirkstoffkombination
Andere Studien-ID-Nummern
- RV 392
- WRAIR 2393 (Andere Kennung: WRAIR)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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