Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002419 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment
Official Title ^ICMJE	A Phase II, 24-Week, Open-Label Study Designed to Evaluate the Safety, Tolerability, and Efficacy of Novel Quadruple-Combination Therapy With Preveon (Adefovir Dipivoxil; Bis-POM PMEA), Abacavir (1592U89), Sustiva (Efavirenz; DMP-266), and Amprenavir (141W94) for the Treatment of HIV-1 Infection in Patients Who Have Failed Previous Protease Inhibitor Treatment
Brief Summary	The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil plus abacavir (ABC) plus efavirenz (EFV) plus amprenavir (APV) to HIV-infected patients who have failed to respond to previous treatment with protease inhibitors (PIs).
Detailed Description	Patients receive a treatment regimen of adefovir dipivoxil, abacavir, efavirenz, and amprenavir for 24 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. Patients who experience virologic failure are discontinued from the study. After Week 24, patients with documented virologic response are eligible to continue receiving the study treatment and to attend scheduled follow-up visits.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Abacavir sulfate Drug: Amprenavir Drug: Efavirenz Drug: Adefovir dipivoxil
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	25
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Had an HIV level of at least 2,000 copies/ml after 6 months of treatment with at least 1 PI other than amprenavir (meaning you failed PI treatment). Are at least 13 years old (need consent of parent or guardian if under 18). Are able to complete the study. Agree to use effective barrier methods of birth control, such as condoms, during the study. Exclusion Criteria You will not be eligible for this study if you: Have certain serious medical conditions, including AIDS-related cancers (except Kaposi's sarcoma) that require treatment during the study. Have ever taken or are allergic to adefovir dipivoxil, ABC, APV, EFV. Are participating in another anti-HIV drug trial during this study. Have taken certain medications within 30 days prior to study entry, including medications that affect your immune system. Have been diagnosed with hepatitis within the past 30 days. Abuse alcohol or drugs. Are pregnant or breast-feeding. Have ever taken NNRTIs. Have ever taken ddI or d4T. Have received chemotherapy or radiation therapy within 30 days prior to study entry.
Gender	Both
Ages	13 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002419
Responsible Party
Study ID Numbers ^ICMJE	299A, ICC 605
Study Sponsor ^ICMJE	Gilead Sciences
Collaborators ^ICMJE	Glaxo Wellcome Dupont Applied Biosciences
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	November 1999
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP