A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00082394

Collaborator

(none)

Locations

22.1

Actual Duration (Months)

Study Details

Study Description

Brief Summary

The aim of this study was to assess whether TRIZIVIR, administered twice-daily was as safe, tolerable and efficacious as a combination of the drugs COMBIVIR administered twice-daily and atazanavir administered once daily. Over the course of 48 weeks, various parameters that measure safety, tolerability and efficacy of the investigational drugs were measured and compared.

Condition or Disease	Intervention/Treatment	Phase
Infection, Human Immunodeficiency Virus I HIV Infection	Drug: Trizivir Drug: atazanavir Drug: Combivir	Phase 4

Detailed Description

A Phase IV Randomized, Multicenter, Open-Label Study to Compare the Safety, Tolerability and Efficacy of Trizivir (abacavir 300mg, lamivudine 150mg, and zidovudine 300mg) BID vs Combivir (lamivudine 150mg and zidovudine 300mg) BID plus atazanavir 400mg QD in Antiretroviral Naive HIV-1 Infected Subjects over 48 Weeks

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

A Phase IV Randomized, Multicenter, Open-Label Study to Compare the Safety, Tolerability and Efficacy of Trizivir (Abacavir 300mg, Lamivudine 150mg, and Zidovudine 300mg) BID vs Combivir (Lamivudine 150mg and Zidovudine 300mg) BID Plus Atazanavir 400mg QD in Antiretroviral Naive HIV-1 Infected Subjects Over 48 Weeks

Actual Study Start Date :

Apr 26, 2004

Actual Primary Completion Date :

Mar 1, 2006

Actual Study Completion Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

The primary endpoint was drug efficacy, measured as the proportion of study subjects who had plasma HIV-1 RNA less than 50 copies/mL at week 48 and did not meet the definition of virologic failure through this timepoint. [48 Weeks]

Secondary Outcome Measures

% patients with plasma HIV-1 RNA <50 and <400 copies/mL at weeks 24 & 48; Change from BL in plasma HIV-1 RNA and CD4+ measures; AEs; Time to virologic failure [48 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Adults with documented HIV-1 infection.
Past use of HIV drugs must have been less than 15 days.
Plasma HIV-1 RNA between 500 and 20,000 copies/mL.
CD4+ cell count greater than 100 cells/mm3.
Willing/able to provide written informed consent.

Exclusion criteria:

Have AIDS at screening.
Pregnant or breastfeeding.
Underlying medical conditions considered to be significant for this protocol.
Participating in other investigational drug trials.
In the opinion of the investigator, would be unable to complete 48 weeks of dosing.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Bakersfield	California	United States	93301
2	GSK Investigational Site	Los Angeles	California	United States	90069
3	GSK Investigational Site	Oakland	California	United States	94609
4	GSK Investigational Site	San Francisco	California	United States	94121
5	GSK Investigational Site	Fort Collins	Colorado	United States	80528
6	GSK Investigational Site	Washington, D.C.	District of Columbia	United States	20007
7	GSK Investigational Site	Fort Lauderdale	Florida	United States	33145
8	GSK Investigational Site	Fort Lauderdale	Florida	United States	33306
9	GSK Investigational Site	Fort Lauderdale	Florida	United States	33308
10	GSK Investigational Site	Fort Myers	Florida	United States	33901
11	GSK Investigational Site	Miami Beach	Florida	United States	33140
12	GSK Investigational Site	Miami	Florida	United States	33136
13	GSK Investigational Site	Orlando	Florida	United States	32804
14	GSK Investigational Site	Atlanta	Georgia	United States	30339
15	GSK Investigational Site	Decatur	Georgia	United States	30033
16	GSK Investigational Site	Chicago	Illinois	United States	60637
17	GSK Investigational Site	Wichita	Kansas	United States	67214
18	GSK Investigational Site	Louisville	Kentucky	United States	40202
19	GSK Investigational Site	New Orleans	Louisiana	United States	70112
20	GSK Investigational Site	New Orleans	Louisiana	United States	70115
21	GSK Investigational Site	New Orleans	Louisiana	United States	70127-0800
22	GSK Investigational Site	Saint Louis	Missouri	United States	63139
23	GSK Investigational Site	East Orange	New Jersey	United States	7017
24	GSK Investigational Site	Hillsborough	New Jersey	United States	08876
25	GSK Investigational Site	Newark	New Jersey	United States	7102
26	GSK Investigational Site	Voorhees	New Jersey	United States	08043
27	GSK Investigational Site	Mount Vernon	New York	United States	10550
28	GSK Investigational Site	Valhalla	New York	United States	10595
29	GSK Investigational Site	Charlotte	North Carolina	United States	28209
30	GSK Investigational Site	Greenville	North Carolina	United States	27858-4354
31	GSK Investigational Site	Akron	Ohio	United States	44304
32	GSK Investigational Site	Portland	Oregon	United States	97219
33	GSK Investigational Site	Allentown	Pennsylvania	United States	18102
34	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19140
35	GSK Investigational Site	West Reading	Pennsylvania	United States	19611
36	GSK Investigational Site	Columbia	South Carolina	United States	29203
37	GSK Investigational Site	Greenville	South Carolina	United States	29605
38	GSK Investigational Site	Austin	Texas	United States	78705
39	GSK Investigational Site	Dallas	Texas	United States	75208
40	GSK Investigational Site	Dallas	Texas	United States	75246
41	GSK Investigational Site	Harlingen	Texas	United States	78550
42	GSK Investigational Site	Houston	Texas	United States	77027
43	GSK Investigational Site	Hampton	Virginia	United States	23666
44	GSK Investigational Site	Guadalajara	Jalisco	Mexico	44340
45	GSK Investigational Site	Monterrey	Nuevo León	Mexico	64460