Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)

Sponsor

Glaxo Wellcome (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00004981

Collaborator

(none)

230

Enrollment

Locations

9.2

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to look at the safety and effectiveness of a pill called Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). In this study, Trizivir will be compared to Combivir plus abacavir.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Abacavir sulfate, Lamivudine and Zidovudine Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate	Phase 3

Detailed Description

Patients are randomized to receive either the triple combination tablet (Trizivir) or to receive Combivir plus abacavir as a separate tablet. Patients take their study medications for 24 weeks.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Phase IIIB Randomized, Multicenter Study of the Efficacy and Safety of Combivir 1 Tablet Po Bid Plus Ziagen 300mg Po Bid Versus an Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg Combination Tablet Po Bid, Administered for 24 Weeks in Subjects With HIV-1 Infection

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 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 18 years old.
Are HIV-positive.
Are currently receiving one of the following anti-HIV drug combinations: Combivir plus abacavir, Combivir plus abacavir plus a protease inhibitor, or Combivir plus abacavir plus a non-nucleoside reverse transcriptase inhibitor (NNRTI). Patients must have been taking this drug combination for at least the past 16 weeks. This also must be the first anti-HIV drug combination the patient has received.
Have a viral load (level of HIV in the blood) less than or equal to 400 copies/ml.
Have CD4+ cell count greater than 200 cells/mm3.
Agree to use effective methods of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have been diagnosed with AIDS.
Have a gastrointestinal disorder that makes it difficult for patients to absorb food or to take medications by mouth.
Have hepatitis.
Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease.
Are allergic to any of the study drugs.
Abuse alcohol or drugs.
Will not be available for the entire 24-week study period.
Are pregnant or breast-feeding.
Have taken or will need to take certain medications, including radiation therapy, chemotherapy, drugs that affect the immune system (such as interleukin), an HIV vaccine, foscarnet, and hydroxyurea.
Are enrolled in another experimental drug study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AIDS Healthcare Foundation	Los Angeles	California	United States	900276069
2	Tower Infectious Disease Med Ctr	Los Angeles	California	United States	90048
3	Robert Scott MD	Oakland	California	United States	94609
4	St Lukes Medical Group	San Diego	California	United States	92101
5	Georgetown Univ Med Ctr	Washington	District of Columbia	United States	20007
6	Whitman Walker Clinic	Washington	District of Columbia	United States	20009
7	Univ of Miami School of Medicine	Miami	Florida	United States	33136
8	Specialty Med Care Ctrs of South Florida Inc	Miami	Florida	United States	33142
9	Saint Josephs Comprehensive Research Institute	Tampa	Florida	United States	33607
10	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	30308
11	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
12	New England Med Ctr	Boston	Massachusetts	United States	02111
13	Research Med Ctr	Kansas City	Missouri	United States	64111
14	Addiction Research and Treatment Corp	Brooklyn	New York	United States	11201
15	Saint Vincent's Hosp and Med Ctr	New York	New York	United States	10011
16	St Luke Roosevelt Hosp	New York	New York	United States	10011
17	Lehigh Valley Hosp	Allentown	Pennsylvania	United States	18105
18	Hahnemann Univ Hosp	Philadelphia	Pennsylvania	United States	191021192
19	Anderson Clinical Research	Pittsburgh	Pennsylvania	United States	15213
20	Burnside Clinic	Columbia	South Carolina	United States	29206
21	Univ of Tennessee	Memphis	Tennessee	United States	38163
22	Nashville Health Management Foundation / Vanderbilt Univ	Nashville	Tennessee	United States	37203
23	Nicholas Bellos	Dallas	Texas	United States	75246
24	Univ of Texas Med Branch	Galveston	Texas	United States	77555
25	Therapeutic Concepts	Houston	Texas	United States	77004