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
This study has been completed.
Sponsor:
Gilead Sciences
Collaborators:
Bristol-Myers Squibb
Glaxo Wellcome
Dupont Applied Biosciences
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002234
First received: August 30, 2001
Last updated: June 23, 2005
Last verified: November 2004
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Efavirenz Drug: Adefovir dipivoxil Drug: Lamivudine Drug: Didanosine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
| Estimated Enrollment: | 25 |
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.
Eligibility| Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002234
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002234
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 History of Changes |
| Other Study ID Numbers: | 232J ICC 604 |
| Study First Received: | August 30, 2001 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
Drug Therapy, Combination Reverse Transcriptase Inhibitors Anti-HIV Agents |
Additional relevant MeSH terms:
|
Infection HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Efavirenz Lamivudine Reverse Transcriptase Inhibitors Adefovir Adefovir dipivoxil |
Didanosine Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective 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 Anti-HIV Agents Antimetabolites |
ClinicalTrials.gov processed this record on September 23, 2016