Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)

Comparison of HIV RNA Suppression Produced by Triple Regimens Containing Either Didanosine Enteric Coated or Didanosine Formulations Each Administered Once Daily

Patrocinadores

Patrocinador principal: Bristol-Myers Squibb

Fuente Bristol-Myers Squibb
Resumen breve

Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and hopefully will prevent stomach upset. The purpose of this study is to compare the effectiveness of ddI EC versus the standard form of ddI. Both forms of ddI will be given with stavudine (d4T) plus nelfinavir (NLF).

Descripción detallada

Patients are randomized to 1 of 2 open-label treatment groups. Group 1 receives ddI EC plus d4T plus NLF for 48 weeks. Group 2 receives ddI plus d4T plus NLF for 48 weeks. Both forms of ddI are administered orally once daily. Antiviral activity is determined by the magnitude and the duration of reduction of plasma HIV RNA from baseline through Week 24.

Estado general Completed
Fecha de inicio March 1999
Fecha de Terminación March 1999
Fecha de finalización primaria March 1999
Fase Phase 3
Tipo de estudio Interventional
Inscripción 120
Condición
Intervención

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

You may be eligible for this study if you:

- Are HIV-positive.

- Are at least 18 years old.

- Have a viral load of at least 5,000 copies/ml and a CD4 count of at least 100 cells/mm3.

Exclusion Criteria

You will not be eligible for this study if you:

- Have received more than 4 weeks of treatment with nucleoside anti-HIV medications (NRTIs), or more than 1 week with protease inhibitors. (All anti-HIV treatments other than study medications must be stopped at least 14 days prior to study entry.)

- Have severe diarrhea.

- Are pregnant or breast-feeding.

- Have a history of pancreatic disease or any other serious condition.

- Have hepatitis within 30 days prior to study entry.

- Cannot take medications by mouth.

- Have received certain medications.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Ubicación
Instalaciones:
Sorra Research Ctr / Med Forum | Birmingham, Alabama, 35203, United States
AIDS Healthcare Foundation | Los Angeles, California, 900276069, United States
Robert Scott MD | Oakland, California, 94609, United States
Beacon Clinic / Boulder Community Hosp | Boulder, Colorado, 80304, United States
Community Health Care | Fort Lauderdale, Florida, 33306, United States
Immunity Care and Research Inc | Fort Lauderdale, Florida, 33311, United States
HIV Clinical Research Ctr | Fort Lauderdale, Florida, 33316, United States
South Shore Hosp | Miami, Florida, 33139, United States
Saint Josephs Comprehensive Research Institute | Tampa, Florida, 33607, United States
AIDS Research Consortium of Atlanta | Atlanta, Georgia, 303081962, United States
Chicago Ctr for Clinical Research | Chicago, Illinois, 60610, United States
Univ of Kansas School of Medicine | Wichita, Kansas, 672143124, United States
Univ of Nebraska Med Ctr | Omaha, Nebraska, 681985400, United States
Clinical Studies of Las Vegas | Las Vegas, Nevada, 89128, United States
Anderson Clinical Research Inc | Rego Park, New York, 11374, United States
Anderson Clinical Research Inc | Reading, Pennsylvania, 19604, United States
Coastal Carolina Research Ctr | Mount Pleasant, South Carolina, 29464, United States
Oak Lawn Physicians Group | Dallas, Texas, 75219, United States
Univ of Texas Southwestern Med Ctr of Dallas | Dallas, Texas, 752359103, United States
Nicholaos Bellos | Dallas, Texas, 75246, United States
Houston Clinical Research Network / Div of Montrose Clinic | Houston, Texas, 77006, United States
Swedish Med Ctr | Seattle, Washington, 98122, United States
Clinique Medicale du Quartier Latin | Montreal, Quebec, Canada
Clinique Medicale L'Actuele | Montreal, Quebec, Canada
Ubicacion Paises

Canada

United States

Fecha de verificación

April 2011

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov