A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients

Sponsor

Glaxo Wellcome (Industry)

Overall Status

Completed

CT.gov ID

NCT00005106

Collaborator

(none)

230

Enrollment

Locations

5.9

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to look at the effects of different anti-HIV drug combinations on body fat changes in HIV-positive patients who have never received anti-HIV therapy before.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate Drug: Nelfinavir mesylate Drug: Lamivudine Drug: Stavudine	Phase 4

Detailed Description

Patients are randomized to receive stavudine plus lamivudine plus nelfinavir, Combivir (zidovudine plus lamivudine) plus nelfinavir, or Combivir plus abacavir. Patients are stratified into 2 groups based on their screening plasma HIV-1 RNA: (1) greater than 1,000 up to 100,000 copies/ml or (2) greater than 100,000 up to 200,000 copies/ml. Measurements and evaluations for assessment of body fat composition, virologic and immunologic outcomes, markers of alterations in carbohydrate and lipid metabolism, and safety are performed at Baseline, Weeks 4, 8, 16, 24, and every 12 weeks thereafter until Week 96 or withdrawal. In addition, health-related quality of life and health care resource utilization data are collected at specified treatment visits.

Study Design

Study Type:

Interventional

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

A 96-Week, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Tolerability of the Antiretroviral Activity of Stavudine (40mg BID) Plus Lamivudine (150mg BID) Plus Nelfinavir (1250mg BID) Versus Abacavir (300mg BID) Plus Combivir (3TC 150mg/ZDV 300mg BID) Versus Combivir (3TC 150mg/ZDV 300mg BID) Plus Nelfinavir (1250mg BID) in HIV-1 Infected Subjects

Study Start Date :

Sep 1, 1999

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.
Have a CD4 count greater than 50 cells/mm3.
Have a viral load greater than 1,000 copies/ml but less than 200,000 copies/ml.
Have never received anti-HIV medications before. (However, less than 1 week of therapy with lamivudine or a protease inhibitor and less than 4 weeks of therapy with other nucleoside reverse transcriptase inhibitors [NRTIs] is allowed. No therapy with nonnucleoside reverse transcriptase inhibitors [NNRTIs] is allowed.)
Cannot bear children or agree to use effective methods of birth control during the study. Hormonal methods of birth control (such as birth control pills) are not considered effective for this study.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have an active AIDS-defining opportunistic infection or disease that, in the doctor's opinion, would make them unable to participate.
Are unable, in the opinion of the doctor, to follow the dosing schedule and follow-up visit schedule.
Have a substance abuse problem that would interfere with taking the medications correctly or attending the clinic visits.
Are enrolled in another study.
Cannot take medications by mouth or absorb drugs.
Have hepatitis.
Have a serious medical condition such as diabetes, congestive heart failure, or other heart disease.
Need chemotherapy or radiation therapy (except for local treatment of Kaposi's sarcoma).
Are taking certain medications.
Are pregnant or breast-feeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	352942050
2	Arizona Clinical Research Ctr Inc	Tucson	Arizona	United States	85712
3	Longbeach Memorial Med Ctr	Longbeach	California	United States	90806
4	Good Samaritan Hosp	Los Angeles	California	United States	90004
5	THE Clinic	Los Angeles	California	United States	90008
6	AIDS Healthcare Foundation	Los Angeles	California	United States	900276069
7	Maxine Liggins	Los Angeles	California	United States	90042
8	UCLA Care Ctr	Los Angeles	California	United States	90095
9	Highland Gen Hosp / San Francisco Gen Hosp	Oakland	California	United States	946021018
10	San Francisco Gen Hosp	San Francisco	California	United States	94110
11	Georgetown Univ Med Ctr	Washington	District of Columbia	United States	20007
12	IDC Research Initiative	Altamonte Springs	Florida	United States	32701
13	Children's Diagnostic Treatment Ctr	Fort Lauderdale	Florida	United States	33301
14	Community Health Care	Fort Lauderdale	Florida	United States	33306
15	Comprehensive Care Center	Fort Lauderdale	Florida	United States	33316
16	Univ of Miami School of Medicine	Miami	Florida	United States	33136
17	South Shore Hosp	Miami	Florida	United States	33139
18	Orange County Health Dept	Orlando	Florida	United States	32805
19	Immunity Care and Research Inc	Plantation	Florida	United States	33324
20	Daniel Seekins	Tampa	Florida	United States	33607
21	Infectious Disease Research Institute	Tampa	Florida	United States	33614
22	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	30308
23	Ponce de Leon Ctr	Atlanta	Georgia	United States	30308
24	Philip Brachman	Atlanta	Georgia	United States	30309
25	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
26	Cook County Hosp	Chicago	Illinois	United States	60614
27	HIV Outpatient Clinics / LA State Univ Med Ctr	New Orleans	Louisiana	United States	70112
28	Beth Israel Deaconess Med Ctr	Boston	Massachusetts	United States	02215
29	Univ of Missouri at Kansas City School of Medicine	Kansas City	Missouri	United States	64108
30	South Jersey Infectious Diseases Inc	Somers Point	New Jersey	United States	08244
31	WNC Community Health Services	Asheville	North Carolina	United States	28806
32	Carolinas Med Ctr	Charlotte	North Carolina	United States	28232
33	Summa Health System	Akron	Ohio	United States	44304
34	MCP Hahnemann Univ Hosp	Philadelphia	Pennsylvania	United States	19102
35	Miriam Hosp	Providence	Rhode Island	United States	02906
36	Univ of Texas Southwestern Med Ctr	Dallas	Texas	United States	75235
37	Thomas Street Clinic	Houston	Texas	United States	77009
38	Univ TX San Antonio Health Science Ctr	San Antonio	Texas	United States	782847881
39	Hampton Roads Med Specialists	Hampton	Virginia	United States	23666