Beverly Hills, California 90211

  • HIV Infections

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

232J


NCT ID:

NCT00002234


Secondary ID:

ICC 604


Study Acronym:


Brief Title:

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


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 Ep


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

13 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bristol-Myers Squibb


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Primary Pu


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:


Study Dates

Verification Date:November 2004
Last Changed Date:June 23, 2005
First Received Date:August 30, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Efavirenz
Intervention Type:Drug
Name:Adefovir dipivoxil
Intervention Type:Drug
Name:Lamivudine
Intervention Type:Drug
Name:Didanosine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Gilead Sciences
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Bristol-Myers Squibb

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 07, 2020

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