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
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00002234 |
Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Efavirenz Drug: Adefovir dipivoxil Drug: Lamivudine Drug: Didanosine | Phase 2 |
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 |

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002234
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 |
ClinicalTrials.gov Identifier: | NCT00002234 |
Other Study ID Numbers: |
232J ICC 604 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | November 2004 |
Drug Therapy, Combination Reverse Transcriptase Inhibitors Anti-HIV Agents |
Infections Lamivudine Efavirenz Didanosine Adefovir Adefovir dipivoxil Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antiviral Agents |
Anti-Infective Agents Anti-HIV Agents Anti-Retroviral 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 |