A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3 - Tabular View

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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3

This study has been completed.

Study NCT00002161. Last updated on June 23, 2005. Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3
Official Title ^†	A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3
Brief Summary	To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA ) in combination with standard antiretroviral therapy for 48 weeks.
Detailed Description	Patients are randomized to receive either adefovir dipivoxil or placebo daily for 24 weeks, after which all patients will receive open-label drug for an additional 24 weeks. Study drug is administered in combination with a current antiretroviral regimen for the entire 48 weeks. Patients are followed every 4 weeks during the first 24 weeks of study, then every 8 weeks during the last 24 weeks.
Study Phase
Study Type ^†	Interventional
Study Design ^†	Treatment, Double-Blind, Safety Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	HIV Infections
Intervention ^†	Drug: Adefovir dipivoxil
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	400
Start Date ^†
Completion Date
Eligibility Criteria ^†	Inclusion Criteria Patients must have: HIV infection with HIV RNA titer >= 2500 copies/ml (2.5 KEq/ml) plasma. CD4 count >= 200 cells/mm3. No new AIDS-defining event within the past 2 months. Life expectancy at least 1 year. Consent of parent or guardian if less than 18 years old. Tolerated antiretroviral therapy for the past 2 months. NOTE: Kaposi's sarcoma is permitted provided patient has not received systemic therapy within the past month. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Active, serious infections other than HIV that require parenteral antibiotic or antiviral therapy. Gastrointestinal malabsorption syndrome or chronic nausea or vomiting that would preclude oral medication. Malignancy other than Kaposi's sarcoma or basal cell carcinoma. Concurrent Medication: Excluded: Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons. Isoniazid. Rifampin. Investigational agents (unless approved by sponsor). Systemic chemotherapeutic agents. Prior Medication: Excluded: Parenteral antibiotic or antiviral therapy for another active, serious infection within the past 2 weeks. Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons within the past month. Systemic therapy for KS within the past month. Required: Antiretroviral regimen other than study drug. Required: Antiretroviral therapy for at least the past 2 months. Current alcohol or substance abuse that would interfere with compliance.
Gender	Both
Ages	13 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00002161
Organization ID	232C
Secondary IDs ^††	GS-96-408
Study Sponsor ^†	Gilead Sciences
Collaborators ^††
Investigators ^†
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	May 1997
First Received Date ^†	November 2, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.