A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Recent HIV Infection

A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Recent HIV Infection

Patrocinadores

Patrocinador principal: Bristol-Myers Squibb

Fuente Bristol-Myers Squibb
Resumen breve

To assess the magnitude and duration of the antiviral activity in plasma and the incidence and time to total suppression of detectable HIV RNA in plasma. To assess the long-term safety and tolerability of this combination therapy and the magnitude and duration of the effect of these drugs over CD4 cell counts.

Estado general Completed
Fecha de inicio May 1997
Fecha de Terminación March 2000
Fecha de finalización primaria March 2000
Fase N/A
Tipo de estudio Interventional
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Hydroxyurea

Tipo de intervención: Drug

Nombre de intervención: Nelfinavir mesylate

Tipo de intervención: Drug

Nombre de intervención: Stavudine

Tipo de intervención: Drug

Nombre de intervención: Didanosine

Elegibilidad

Criterios:

Inclusion Criteria

Patients must have the following symptoms and conditions:

- Treatment naive.

- Recent HIV infection.

- Baseline laboratory values within acceptable ranges.

- Written, informed consent from parent or legal guardian for patients < 18 years old.

- Available for follow-up for at least 96 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions and symptoms are excluded:

- Documentation of other cause for previously mentioned clinical conditions.

- Intractable diarrhea.

- Signs and symptoms of bilateral peripheral neuropathy >= Grade 2.

- Inability to tolerate oral medication.

- Hemophilia, other bleeding disorder, or no accessible tonsillar or lymph node tissue.

Patients with the following prior conditions are excluded:

History of acute or chronic pancreatitis. 1. Use of potent neurotoxic drugs is not permitted.

- No other anti-HIV therapy allowed.

- Nelfinavir should not be administered concurrently with rifampin or rifabutin, terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion), and midazolam (Versed).

1. Any prior antiretroviral therapy.

- Prior vaccination with a candidate HIV therapeutic vaccine.

- Previous therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment.

- Previous therapy with rifampin or rifabutin, terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion), and midazolam (Versed) within 14 days prior to study entry or at any time while on study.

Active alcohol or substance abuse.

Género: All

Edad mínima: 16 Years

Edad máxima: N/A

Voluntarios Saludables: No

Ubicación
Instalaciones: Univ of California at San Francisco Gen Hosp
Ubicacion Paises

United States

Fecha de verificación

April 2011

Palabras clave
Condición Examinar
Información de diseño del estudio

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov