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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002161 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	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 ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Adefovir dipivoxil
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	400
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002161
Responsible Party
Study ID Numbers ^ICMJE	232C, GS-96-408
Study Sponsor ^ICMJE	Gilead Sciences
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	May 1997
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP