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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002161
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1997
  Purpose

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 Intervention
HIV Infections
Drug: Adefovir dipivoxil

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
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 NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 400
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002161

  Show 27 Study Locations
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002161     History of Changes
Other Study ID Numbers: 232C, GS-96-408
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Adefovir
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on August 28, 2014