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
1 other identifier
interventional
120
2 countries
15
Brief Summary
To evaluate the safety and tolerance of the combination of adefovir dipivoxil at two comparative doses and nelfinavir plus saquinavir SGC administered orally (Group 1) vs. the combination of adefovir dipivoxil and nelfinavir plus either zidovudine, lamivudine, or stavudine (Group 2) vs. the combination of adefovir dipivoxil and saquinavir SGC plus either zidovudine, lamivudine, or stavudine (Group 3) in HIV-infected patients with prior nucleoside reverse transcriptase inhibitor therapy but no prior exposure to protease inhibitors who have CD4 cell counts \>= 100 cells/mm3 and an HIV-1 RNA baseline copy number \>= 5000 copies/ml. To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (\<500 copies/ml) at 20 weeks of study therapy and the average reduction in HIV-1 RNA from baseline through study week 20. To evaluate the durability of the antiviral response through 48 weeks of study in patients who continue on study therapy after week 24.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
October 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- \. 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.
- \. 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (15)
Phoenix Body Positive
Phoenix, Arizona, 85016, United States
Krauss Med Partners / Dept of Research and Development
Los Angeles, California, 90036, United States
UCLA Care Ctr
Los Angeles, California, 900951793, United States
Davies Med Ctr
San Francisco, California, 94114, United States
Blick Med Associates
Greenwich, Connecticut, 06830, United States
George Washington Med Ctr
Washington D.C., District of Columbia, 20037, United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 21287, United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655, United States
North Shore Community Hosp
Manhassett, New York, 11030, United States
Associates of Med and Mental Health
Tulsa, Oklahoma, 74114, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, 02860, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235, United States
Hosp Regional de Ponce - Area Vieja
Ponce, 00731, Puerto Rico
San Juan AIDS Program
Santruce, 00908, Puerto Rico