A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patient
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ClinicalTrials.gov Identifier: NCT00002184 |
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: Nelfinavir mesylate Drug: Levocarnitine Drug: Adefovir dipivoxil Drug: Saquinavir Drug: Lamivudine Drug: Stavudine Drug: Zidovudine | Phase 2 |
This protocol is a stratified, randomized, double-blind, dose-comparative study of the safety and efficacy of adefovir dipivoxil in combination with nelfinavir and saquinavir soft gel capsules (SGC) or adefovir dipivoxil in combination with nelfinavir or saquinavir SGC plus a nucleoside analog (zidovudine, lamivudine, or stavudine).
Patients will be randomized to adefovir dipivoxil with nelfinavir and saquinavir or adefovir dipivoxil with nelfinavir or saquinavir plus a nucleoside analog (zidovudine, lamivudine, or stavudine). Within each treatment arm, patients will be randomized to 1 of 2 doses of adefovir dipivoxil in a blinded manner. Patients randomized to receive a nucleoside analog will then be assigned to receive either zidovudine, lamivudine, or stavudine based upon their previous RTI therapy. A daily dose of L-carnitine will be administered to all patients.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 120 participants |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 100/mm3 and HIV-1 RNA Copy Numbers >= 5,000 Copies/Ml and Prior RTI Therapy But No Prior PI Therapy |


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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
- Laboratory diagnosis of HIV infection (positive HIV antibody test confirmed by Western blot, p24 antigen assay, HIV-1 RNA, or HIV-1 culture).
- An HIV-1 RNA plasma titer >= 5000 copies/ml within 14-21 days prior to the baseline visit.
- CD4 cell count >= 100 cells/mm3 within 14-21 days prior to the baseline visit.
- A minimum life expectancy of at least 1 year.
- Signed, informed consent from parent or legal guardian for those patients < 18 years of age.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms and conditions are excluded:
- Active, serious infections (other than HIV infection) requiring parenteral antibiotic or antiviral therapy. Patients will be considered recovered from such infectious episodes if at least 2 weeks elapsed following the cessation of parenteral therapy before the baseline visit.
- Exhibiting evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting that may confer an inability to receive an orally administered medication.
- Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Patients with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 4 weeks prior to baseline and are not anticipated to require systemic therapy during the study.
- Any other clinical condition that in the opinion of the investigator would make the patient unsuitable for study or unable to comply with the dosing requirements.
Patients with any of the following prior conditions are excluded:
- A new AIDS-defining event diagnosed within 1 month prior to baseline.
-
Significant history of peripheral neuropathy.
1. Treatment with immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
-
Ritonavir, indinavir, nevirapine, delavirdine, didanosine, dideoxycytidine, interferon alpha, interferon beta, isoniazid, rifampin, investigational agents (except upon Sponsor approval), chemotherapeutic agents (systemic), terfenadine, astemizole, cisapride, triazolam, and midazolam.
1. Prior use of adefovir dipivoxil.
- Prior use of any antiretroviral protease inhibitor.
- Immunizations within 30 days of baseline.
- Antiretroviral vaccine therapy within 60 days of baseline.
- Treatment in the 4 weeks prior to baseline with immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
- Any other investigational drug within 30 days prior to baseline.
- Any prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements.
Required:
Prior therapy for > 4 weeks with any licensed nucleoside analog inhibitor of HIV reverse transcriptase.
Patients with current alcohol or substance abuse judged by the investigator to potentially interfere with patient 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): NCT00002184
United States, Arizona | |
Phoenix Body Positive | |
Phoenix, Arizona, United States, 85016 | |
United States, California | |
Krauss Med Partners / Dept of Research and Development | |
Los Angeles, California, United States, 90036 | |
UCLA Care Ctr | |
Los Angeles, California, United States, 900951793 | |
Davies Med Ctr | |
San Francisco, California, United States, 94114 | |
United States, Connecticut | |
Blick Med Associates | |
Greenwich, Connecticut, United States, 06830 | |
United States, District of Columbia | |
George Washington Med Ctr | |
Washington, District of Columbia, United States, 20037 | |
United States, Maryland | |
Johns Hopkins Univ School of Medicine | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Univ of Massachusetts Med Ctr | |
Worcester, Massachusetts, United States, 01655 | |
United States, New York | |
North Shore Community Hosp | |
Manhassett, New York, United States, 11030 | |
United States, Oklahoma | |
Associates of Med and Mental Health | |
Tulsa, Oklahoma, United States, 74114 | |
United States, Pennsylvania | |
Univ of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Rhode Island | |
Mem Hosp of Rhode Island | |
Pawtucket, Rhode Island, United States, 02860 | |
United States, Texas | |
Univ of Texas Southwestern Med Ctr of Dallas | |
Dallas, Texas, United States, 75235 | |
Puerto Rico | |
Hosp Regional de Ponce - Area Vieja | |
Ponce, Puerto Rico, 00731 | |
San Juan AIDS Program | |
Santruce, Puerto Rico, 00908 |
ClinicalTrials.gov Identifier: | NCT00002184 History of Changes |
Other Study ID Numbers: |
232E |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | October 1998 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1 Dose-Response Relationship, Drug Drug Therapy, Combination Acquired Immunodeficiency Syndrome Zidovudine Stavudine HIV Protease Inhibitors CD4 Lymphocyte Count |
Lamivudine RNA, Viral Saquinavir Nelfinavir Reverse Transcriptase Inhibitors Adenine Anti-HIV Agents Viral Load |
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 Lamivudine Zidovudine Adefovir Adefovir dipivoxil Reverse Transcriptase Inhibitors Stavudine |
Nelfinavir Saquinavir Protease Inhibitors HIV Protease Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Antimetabolites Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |