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


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

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

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 |