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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002184

Run by

Gilead Sciences

People needed

120

Last updated by the study team

2005-06-24

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• Phoenix Body Positive — Phoenix, Arizona, United States
• Krauss Med Partners / Dept of Research and Development — Los Angeles, California, United States
• UCLA Care Ctr — Los Angeles, California, United States
• Davies Med Ctr — San Francisco, California, United States
• Blick Med Associates — Greenwich, Connecticut, United States
• George Washington Med Ctr — Washington D.C., District of Columbia, United States
• Johns Hopkins Univ School of Medicine — Baltimore, Maryland, United States
• Univ of Massachusetts Med Ctr — Worcester, Massachusetts, United States
• North Shore Community Hosp — Manhassett, New York, United States
• Associates of Med and Mental Health — Tulsa, Oklahoma, United States
• Univ of Pennsylvania — Philadelphia, Pennsylvania, United States
• Mem Hosp of Rhode Island — Pawtucket, Rhode Island, United States
• Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Hosp Regional de Ponce - Area Vieja — Ponce, Puerto Rico
• San Juan AIDS Program — Santruce, Puerto Rico

Full record on ClinicalTrials.gov

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