Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients

• ClinicalTrials.gov Identifier: NCT00002234
• Recruitment Status: Completed
• First Posted: August 31, 2001
• Last Update Posted: June 24, 2005
• Sponsor: Gilead Sciences
• Collaborators: Bristol-Myers Squibb; Glaxo Wellcome; Dupont Applied Biosciences
• Information provided by: Bristol-Myers Squibb

Study Description

Brief Summary:

The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: Efavirenz; Drug: Adefovir dipivoxil; Drug: Lamivudine; Drug: Didanosine	Phase 2

Detailed Description:

Patients receive a treatment regimen of adefovir dipivoxil, didanosine, efavirenz, and lamivudine for 48 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA and lymphocyte subsets and for the development of adverse experiences and laboratory toxicities. At Weeks 8, 12, 24, and 48, patients are assessed for adherence to study treatment with a questionnaire. Patients who experience virologic failure are discontinued from the study. Patients who experience treatment intolerance may have their antiretroviral treatment regimens changed. After Week 48, patients with documented virologic response are eligible to continue receiving study treatment.

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 25 participants
• Primary Purpose: Treatment
• Official Title: A Phase II, 48 Week, Open-Label Study Designed to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of a Simplified Dosing Regimen of Preveon (Adefovir Dipivoxil; bis-POM PMEA), Videx (Didanosine; ddI), Sustiva (Efavirenz; DMP-266), and Epivir (Lamivudine; 3TC) Administered Once Daily for the Treatment of HIV-1 Infection

Arms and Interventions

Outcome Measures

Eligibility Criteria

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

Criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive.
• Are at least 13 years old (need consent of parent or guardian if under 18).
• Have an HIV count of 5,000 copies/ml or more within 30 days prior to study entry.
• Have a CD4+ count of 50 cells/mm3 or more.

Exclusion Criteria

You will not be eligible for this study if you:

• Are diagnosed with hepatitis within 30 days prior to study entry.
• Have certain serious medical conditions, including an AIDS-defining clinical condition.
• Received chemotherapy or radiation therapy within 30 days of study entry.
• Have taken any nucleoside reverse transcriptase inhibitors (NRTIs) for more than 2 weeks.
• Have ever taken 3TC.
• Have ever taken any non-nucleoside reverse transcriptase inhibitors (NNRTIs).
• Have taken medications that affect your immune system within 30 days prior to study entry.
• Have received a vaccine within 30 days prior to study entry.
• Are enrolled in another anti-HIV drug study while participating in this study.
• Abuse alcohol or drugs.
• Are pregnant or breast-feeding.

Contacts and Locations

Locations

United States, California

Pacific Oaks Med Group

Beverly Hills, California, United States, 90211

United States, Colorado

Univ of Colorado / Health Science Ctr

Denver, Colorado, United States, 80262

United States, Georgia

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States, 30308

United States, Rhode Island

Brown Univ School of Medicine

Providence, Rhode Island, United States, 02908

United States, Virginia

Hampton Roads Med Specialists

Hampton, Virginia, United States, 23666

Sponsors and Collaborators

Gilead Sciences

Bristol-Myers Squibb

Glaxo Wellcome

Dupont Applied Biosciences

More Information

• ClinicalTrials.gov Identifier: NCT00002234
• Other Study ID Numbers: 232J; ICC 604
• First Posted: August 31, 2001
• Last Update Posted: June 24, 2005
• Last Verified: November 2004

Keywords provided by Bristol-Myers Squibb:

Drug Therapy, Combination; Reverse Transcriptase Inhibitors; Anti-HIV Agents

Additional relevant MeSH terms:

Infection; Lamivudine; Efavirenz; Didanosine; Adefovir; Adefovir dipivoxil; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Anti-HIV Agents; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Antimetabolites