Washington, District of Columbia 20009

  • HIV Infections

Purpose:

The purpose of this study is to determine the effect of treatment with Trizivir (TZV) plus efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood).


Study summary:

Patients receive TZV plus EFV in the 48-week Induction Phase. Eligible patients, defined as those with plasma HIV-1 RNA under 50 copies/ml, participate in the 48-week Maintenance Phase. Patients are randomized equally to receive either TZV plus EFV or TZV alone. An immunology substudy will be conducted, including approximately the first 100 patients enrolled who agree to participate.


Criteria:

Inclusion Criteria Patients may be eligible for this study if they: - Are at least 13 years old. - Are HIV-positive. - Have a viral load of at least 5,000 copies/ml. - Agree to use adequate and reliable methods of birth control. Note: Hormonal birth control is not considered adequate. - Provide written consent of a parent or guardian, if under 18 years of age. Exclusion Criteria Patients will not be eligible for this study if they: - Have taken nonnucleoside reverse transcriptase inhibitors. - Have taken other anti-HIV drugs for 2 weeks or more. - Have an opportunistic (AIDS-related) infection. - Are pregnant or breast-feeding. - Have had hepatitis within the past 6 months. - Are allergic to the study drugs or their ingredients. - Have a mental, physical, or substance abuse disorder. - Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease. - Have a gastrointestinal disorder that affects drug absorption or makes it difficult to take medication by mouth. - Have received within 4 weeks before study entry, or may require during the study period, radiation therapy, chemotherapy, or drugs that affect the immune system (such as steroid drugs, interleukins, vaccines, or interferons). - Have received an HIV vaccine within 3 months before study entry, or are scheduled to receive one during the study period. - Require foscarnet or other drugs that are shown to be effective against HIV. - Are taking astemizole, cisapride, midazolam, triazolam, or ergot derivatives. - Are taking experimental drugs. - Are unlikely to complete the study or take the drugs.


Study is Available At:


Original ID:

308B


NCT ID:

NCT00011895


Secondary ID:

ESS40013


Study Acronym:


Brief Title:

Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs


Official Title:

A Phase IV Multicenter Study of the Efficacy and Safety of 48-Week Induction Treatment With TRIZIVIR (Abacavir 300 Mg/Lamivudine 150 Mg/Zidovudine 300 Mg Combination Tablet BID) With Efavirenz (600 Mg QD) Followed by 48-Week Randomized, Open-Label, Mainte


Overall Status:

Active, not recruiting


Study Phase:

Phase 4


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:

NIH AIDS Clinical Trials Information Service


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:

400


Enrollment Type:


Study Dates

Start Date:February 2001
Verification Date:March 2002
Last Changed Date:June 23, 2005
First Received Date:March 2, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Abacavir sulfate, Lamivudine and Zidovudine
Intervention Type:Drug
Name:Efavirenz

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:GlaxoSmithKline

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: March 30, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


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