- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00414518
Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection
An Open-Label Randomized Clinical Trial to Evaluate the Efficacy and Safety of Short Course Antiretroviral Therapy for Acute or Recent HIV-1 Infection in Zimbabwe and the United States
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
About 6 months after infection, HIV viral load reaches a temporarily stable level known as virus set point. Virus set point is different for each patient and can be a predictor for disease progression. Preliminary studies indicate that early, short-term antiretroviral therapy (ART) given to people newly infected with HIV may lead to lower virus set points and preserved CD4 counts. However, the length of short-term treatment needed to balance the possible adverse effects of ART with the achievement of lower virus set point is not yet known. By lowering the virus set point and maintaining CD4 counts, the need for long-term ART may be postponed. The purpose of this study is to determine the safety and efficacy of a short course of ART on producing a lower virus set point in adults recently infected with HIV.
This study will last at least 28 weeks. Participants will be randomly assigned to one of two arms. Arm A will receive ART for 12 weeks as emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) daily and lopinavir/ritonavir (LPV/RTV) in tablet form twice daily. After 12 weeks, treatment will be interrupted unless the CD4 count is measured to be less than 350 cells/mm^3 on two consecutive occasions during treatment interruption. If that occurs therapy will be resumed. Participants in Arm B will receive no treatment until cluster of differentiation 4 (CD4) counts drop below 350 cells/mm^3, indicating ART is needed. Study visits will occur at study entry, at Weeks 2 and 4, and every 4 weeks thereafter. At each study visit, a physical exam, blood collection, and completion of an adherence questionnaire will occur. Participants are encouraged to enroll in a related substudy that will evaluate HIV viral load in genital secretions.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Colorado
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Denver, Colorado, Estados Unidos, 80262
- University of Colorado Health Sciences Center
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308
- AIDS Research Consortium of Atlanta
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Harare, Zimbabue
- University of Zimbabwe College of Health Sciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Acute or recent HIV-1 infection. More information about this criterion can be found in the protocol.
- CD4 count 500 cells/mm3 or greater
- No evidence of prior or current AIDS-defining illness
- No signs or symptoms of HIV infection or AIDS-defining illness that, in the opinion of the investigator, requires ART
- Willing to use acceptable forms of contraception
Exclusion Criteria:
- Prior treatment with any antiretroviral drug for more than 7 days
- Use of certain drugs within 21 days of study entry
- Prior receipt of investigational anti-HIV-1 vaccine
- Ongoing therapy with systemic corticosteroids, chemotherapeutic agents, nephrotoxic systemic agents, immunomodulatory treatments, or investigational agents
- Known allergy/sensitivity to study drugs or their formulations
- Current drug or alcohol use or abuse that, in the opinion of the investigator, may interfere with the study
- Serious medical or psychiatric illness that may interfere with the study
- Hepatitis B infected
- Pregnancy or breastfeeding
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Treatment interruption
Oral Tenofovir disoproxil fumarate/Emtricitabine and Lopinavir/Ritonavir for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher.
When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
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300 mg Tenofovir disoproxil fumarate/ 200 mg emtricitabine tablet taken orally once daily
Otros nombres:
Three 400 mg lopinavir/ 100 mg ritonavir soft gel capsules taken orally twice daily
Otros nombres:
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Experimental: CD4 T cell guided therapy
Anti Retroviral Therapy initiated when AIDS-defining illness occurs or if CD4 count is confirmed at less than 350 mm^3 at two separate, consecutive measurements
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300 mg Tenofovir disoproxil fumarate/ 200 mg emtricitabine tablet taken orally once daily
Otros nombres:
Three 400 mg lopinavir/ 100 mg ritonavir soft gel capsules taken orally twice daily
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms
Periodo de tiempo: At Week 24
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At Week 24
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Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome
Periodo de tiempo: At Week 24
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At Week 24
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Viral Set Point
Periodo de tiempo: Throughout study
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set point is reached after the immune system has developed HIV antibodies and begins to attempt to fight the virus
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Throughout study
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Michelle A. Barron, MD, Division of Infectious Disease, University of Colorado Health Sciences Center
- Silla de estudio: Margaret Borok, MRCP, Department of Medicine, University of Zimbabwe
Publicaciones y enlaces útiles
Publicaciones Generales
- Fidler S, Oxenius A, Brady M, Clarke J, Cropley I, Babiker A, Zhang HT, Price D, Phillips R, Weber J. Virological and immunological effects of short-course antiretroviral therapy in primary HIV infection. AIDS. 2002 Oct 18;16(15):2049-54. doi: 10.1097/00002030-200210180-00010.
- Altfeld M, Rosenberg ES, Shankarappa R, Mukherjee JS, Hecht FM, Eldridge RL, Addo MM, Poon SH, Phillips MN, Robbins GK, Sax PE, Boswell S, Kahn JO, Brander C, Goulder PJ, Levy JA, Mullins JI, Walker BD. Cellular immune responses and viral diversity in individuals treated during acute and early HIV-1 infection. J Exp Med. 2001 Jan 15;193(2):169-80. doi: 10.1084/jem.193.2.169.
- Coombs RW, Speck CE, Hughes JP, Lee W, Sampoleo R, Ross SO, Dragavon J, Peterson G, Hooton TM, Collier AC, Corey L, Koutsky L, Krieger JN. Association between culturable human immunodeficiency virus type 1 (HIV-1) in semen and HIV-1 RNA levels in semen and blood: evidence for compartmentalization of HIV-1 between semen and blood. J Infect Dis. 1998 Feb;177(2):320-30. doi: 10.1086/514213.
- Gallant JE. Current status of antiretroviral treatment interruption and intermittent therapy strategies. MedGenMed. 2002 Sep 19;4(3):19. No abstract available.
- Gulick RM. Structured treatment interruption in patients infected with HIV: a new approach to therapy. Drugs. 2002;62(2):245-53. doi: 10.2165/00003495-200262020-00001.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones transmitidas por la sangre
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Atributos de la enfermedad
- Infecciones por VIH
- Infecciones
- Enfermedades contagiosas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Inhibidores de la transcriptasa inversa
- Inhibidores de la síntesis de ácidos nucleicos
- Inhibidores de enzimas
- Agentes Anti-VIH
- Agentes antirretrovirales
- Inhibidores de la proteasa
- Inhibidores del citocromo P-450 CYP3A
- Inhibidores de enzimas del citocromo P-450
- Inhibidores de la proteasa del VIH
- Inhibidores de la proteasa viral
- Tenofovir
- Emtricitabina
- Ritonavir
- Lopinavir
Otros números de identificación del estudio
- 06-0757
- P01AI055356 (Subvención/contrato del NIH de EE. UU.)
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