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

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ClinicalTrials.gov Identifier: NCT00002161

Recruitment Status : Completed

First Posted : August 31, 2001

Last Update Posted : June 24, 2005

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: Adefovir dipivoxil	Not Applicable

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 Design


Study Type :	Interventional (Clinical Trial)
Enrollment :	400 participants
Masking:	Double
Primary Purpose:	Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Adefovir dipivoxil

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	13 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002161

Show 27 Study Locations

Sponsors and Collaborators

Gilead Sciences

More Information


ClinicalTrials.gov Identifier:	NCT00002161 History of Changes
Other Study ID Numbers:	232C GS-96-408
First Posted:	August 31, 2001 Key Record Dates
Last Update Posted:	June 24, 2005
Last Verified:	May 1997

Keywords provided by NIH AIDS Clinical Trials Information Service:


Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents Adenine

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases	Adefovir Adefovir dipivoxil Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents

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