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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00011895

Collaborator

(none)

400

Enrollment

Locations

9.5

Patients Per Site

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Abacavir sulfate, Lamivudine and Zidovudine Drug: Efavirenz	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

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, Maintenance Treatment With TRIZIVIR With or Without Efavirenz in HIV-1 Infected Antiretroviral Therapy Naive Subjects

Study Start Date :

Feb 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Body Positive	Phoenix	Arizona	United States	85006
2	Health for Life Clinic	Little Rock	Arkansas	United States	72205
3	Orange County Ctr for Special Immunology	Fountain Valley	California	United States	92708
4	Pacific Horizons Med Group	San Francisco	California	United States	94115
5	Beacon Clinic / Boulder Community Hosp	Boulder	Colorado	United States	80304
6	Georgetown Univ Med Ctr	Washington	District of Columbia	United States	20007
7	Dupont Circle Physicians Group	Washington	District of Columbia	United States	200091104
8	Infectious Disease Consultants	Altamonte Springs	Florida	United States	32701
9	North Broward Hosp District / HIV Clinical Research	Fort Lauderdale	Florida	United States	33311
10	SBMA Research	Miami Beach	Florida	United States	33140
11	Univ of Miami / Jackson Memorial Hosp	Miami	Florida	United States	33136
12	Infectious Disease Specialists of Atlanta	Decatur	Georgia	United States	30033
13	Cook County Gen Hosp / Division of Infect Diseases	Chicago	Illinois	United States	60612
14	Northstar Med Clinic	Chicago	Illinois	United States	60657
15	University of Louisville / ID Division	Louisville	Kentucky	United States	40202
16	HIV Outpatient Clinics / LA State Univ Med Ctr	New Orleans	Louisiana	United States	70112
17	Boston Med Ctr	Boston	Massachusetts	United States	02118
18	Dr Paul Benson	Berkley	Michigan	United States	48072
19	Hennepin County Med Ctr	Minneapolis	Minnesota	United States	55415
20	Regions Hosp / HIV/AIDS Program	St. Paul	Minnesota	United States	55101
21	CRC of Mississippi	Jackson	Mississippi	United States	39202
22	Wellness Ctr / Las Vegas	Las Vegas	Nevada	United States	89102
23	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
24	NJCRI	Newark	New Jersey	United States	07103
25	SUNY / Health Sciences Ctr at Brooklyn	Brooklyn	New York	United States	11203
26	Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ	New York	New York	United States	10021
27	ID Consultants	Charlotte	North Carolina	United States	28203
28	East Carolina Univ School of Medicine	Greenville	North Carolina	United States	27858
29	Summa Health System	Akron	Ohio	United States	44304
30	Univ of Oklahoma Infectious Disease Institute	Oklahoma City	Oklahoma	United States	73117
31	Associates in Med and Mental Health	Tulsa	Oklahoma	United States	74114
32	Univ of Tennessee Med Ctr at Knoxville	Knoxville	Tennessee	United States	37920
33	Texas Tech Health Sciences Ctr	El Paso	Texas	United States	79905
34	AIDS Outreach Center	Fort Worth	Texas	United States	76104
35	Metroplex Infectious Disease	Fort Worth	Texas	United States	76104
36	Tarrant County Infectious Diseases Associates	Fort Worth	Texas	United States	76104
37	Therapeutic Concepts	Houston	Texas	United States	77004
38	Diversified Med Practices, PA	Houston	Texas	United States	77027
39	Infectious Diseases Associates of Houston	Houston	Texas	United States	77030
40	Infectious Disease Physicians Inc	Annandale	Virginia	United States	22003
41	Infectious Disease Consultants	Fairfax	Virginia	United States	22030
42	Swedish Med Ctr	Seattle	Washington	United States	98122