A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination With Anti-HIV Therapy (HAART) in HIV-Positive Patients

Study Overview
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Brief Summary
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The purpose of this study is to see if it is safe and effective to give an experimental anti-HIV drug, adefovir dipivoxil (ADV), in combination with other anti-HIV drugs (HAART) to patients who have a viral load (level of HIV in the blood) between 50 and 400 copies/ml.

Detailed Description
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Patients are randomized to 1 of 2 arms in a 2:1 ratio. Approximately 260 patients receive ADV and approximately 130 patients receive placebo. Patients receive ADV or placebo in addition to L-carnitine and their current stable HAART regimen. Each patient receives blinded study medication for 48 weeks and is evaluated at Weeks 16, 24, and 48. Patients who reach the primary endpoint of virologic failure prior to Week 48 may continue blinded study medication or receive open-label ADV at the investigator's discretion. In both cases, patients continue their study visits as per the original visit schedule. Virologic failure is defined as 2 consecutive HIV-1 RNA measurements, after baseline, above 400 copies/ml (measured by the Roche Amplicor HIV-1 Monitor UltraSensitive assay) drawn at least 14 days apart. All patients who complete study visits without treatment-limiting ADV toxicity may continue open-label ADV in the Maintenance Phase at the discretion of the principal investigator.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Adefovir Dipivoxil as Intensification Therapy in Combination With Highly Active Antiretroviral Therapy (HAART) in HIV Infected Patients With HIV-1 RNA > 50 and <= 400 Copies/Ml

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Adefovir dipivoxil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Have been on a stable HAART regimen consisting of at least 3 antiretroviral drugs for at least 16 weeks prior to study entry. Have a CD4 count of 50 cells/mm3 or more. Have a viral load greater than 50 and less than or equal to 400 copies/ml within 14 days prior to study entry. Have had at least 1 additional viral load in the past that was less than or equal to 400 copies/ml while on your current stable HAART regimen.

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Adefovir dipivoxil|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1, RNA, Viral, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load