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KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks

Primary Purpose

HIV Infection, Infection, Human Immunodeficiency Virus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LEXIVA (GW433908)
Ritonavir
KALETRA
EPIVIR
Ziagen
Abacavir/Lamivudine
Fosamprenavir
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring ritonavir, abacavir, HIV, lopinavir, lamivudine, fosamprenavir, Epzicom

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: HIV infected subjects that are naive to anti-HIV therapy. History of a positive HIV test. At least 1000 copies/mL of HIV in their blood as screening. Exclusion Criteria: Active HIV-related diseases. Taking other investigational drugs. Pregnant or breastfeeding females. Not be suitable to participate per investigator opinion.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
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Outcomes

Primary Outcome Measures

Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events.

Secondary Outcome Measures

Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events.

Full Information

First Posted
June 17, 2004
Last Updated
May 12, 2011
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00085943
Brief Title
KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks
Official Title
See Detailed Description
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and tolerability of these compounds over the 48 week study period in patients naive to anti-HIV therapy.
Detailed Description
A Phase IIIB, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of GW433908 (700mg BID) plus ritonavir (100mg BID) Versus Lopinavir/ritonavir (400mg/100mg BID) when Administered in Combination with the Abacavir/Lamivudine (600mg/300mg) Fixed-Dose Combination Tablet QD in Antiretroviral-Naive HIV-1 Infected Adults Over 48 Weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Infection, Human Immunodeficiency Virus
Keywords
ritonavir, abacavir, HIV, lopinavir, lamivudine, fosamprenavir, Epzicom

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
866 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
LEXIVA (GW433908)
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Type
Drug
Intervention Name(s)
KALETRA
Intervention Type
Drug
Intervention Name(s)
EPIVIR
Intervention Type
Drug
Intervention Name(s)
Ziagen
Intervention Type
Drug
Intervention Name(s)
Abacavir/Lamivudine
Intervention Type
Drug
Intervention Name(s)
Fosamprenavir
Other Intervention Name(s)
LEXIVA (GW433908), Ritonavir, Ziagen, KALETRA, Abacavir/Lamivudine, EPIVIR
Primary Outcome Measure Information:
Title
Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events.
Secondary Outcome Measure Information:
Title
Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: HIV infected subjects that are naive to anti-HIV therapy. History of a positive HIV test. At least 1000 copies/mL of HIV in their blood as screening. Exclusion Criteria: Active HIV-related diseases. Taking other investigational drugs. Pregnant or breastfeeding females. Not be suitable to participate per investigator opinion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, Pharm.D.
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
GSK Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90046
Country
United States
Facility Name
GSK Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
GSK Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115-1931
Country
United States
Facility Name
GSK Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
GSK Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
GSK Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
GSK Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
GSK Investigational Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
GSK Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
GSK Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7230
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
GSK Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
GSK Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
GSK Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
GSK Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
GSK Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
GSK Investigational Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
GSK Investigational Site
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
GSK Investigational Site
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
GSK Investigational Site
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
GSK Investigational Site
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
GSK Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
GSK Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10014
Country
United States
Facility Name
GSK Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
GSK Investigational Site
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8091
Country
United States
Facility Name
GSK Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Facility Name
GSK Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
GSK Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
GSK Investigational Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
GSK Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614-5809
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
GSK Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
GSK Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29206-4713
Country
United States
Facility Name
GSK Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
GSK Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
GSK Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
GSK Investigational Site
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
GSK Investigational Site
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
GSK Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
GSK Investigational Site
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
GSK Investigational Site
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
GSK Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
GSK Investigational Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
GSK Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
GSK Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2P 1H9
Country
Canada
Facility Name
GSK Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 6N5
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4T 3A7
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 5B1
Country
Canada
Facility Name
GSK Investigational Site
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
GSK Investigational Site
City
Le Kremlin Bicêtre Cedex
ZIP/Postal Code
94275
Country
France
Facility Name
GSK Investigational Site
City
Lyon Cedex 02
ZIP/Postal Code
69288
Country
France
Facility Name
GSK Investigational Site
City
Lyon Cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
GSK Investigational Site
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
GSK Investigational Site
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
GSK Investigational Site
City
Paris Cedex 14
ZIP/Postal Code
75679
Country
France
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
GSK Investigational Site
City
Saint Denis Cedex 01
ZIP/Postal Code
93205
Country
France
Facility Name
GSK Investigational Site
City
Fuerth
State/Province
Bayern
ZIP/Postal Code
90762
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80331
Country
Germany
Facility Name
GSK Investigational Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
GSK Investigational Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30159
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Facility Name
GSK Investigational Site
City
Ferrara
State/Province
Emilia-Romagna
ZIP/Postal Code
44100
Country
Italy
Facility Name
GSK Investigational Site
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41100
Country
Italy
Facility Name
GSK Investigational Site
City
Rimini
State/Province
Emilia-Romagna
ZIP/Postal Code
47900
Country
Italy
Facility Name
GSK Investigational Site
City
Busto Arsizio (VA)
State/Province
Lombardia
ZIP/Postal Code
21052
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20127
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy
Facility Name
GSK Investigational Site
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10149
Country
Italy
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV 1006
Country
Latvia
Facility Name
GSK Investigational Site
City
Luxembourg
ZIP/Postal Code
1210
Country
Luxembourg
Facility Name
GSK Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-030
Country
Poland
Facility Name
GSK Investigational Site
City
Szczecin
ZIP/Postal Code
71-455
Country
Poland
Facility Name
GSK Investigational Site
City
Wroclaw
ZIP/Postal Code
51-149
Country
Poland
Facility Name
GSK Investigational Site
City
Cascais
ZIP/Postal Code
2750
Country
Portugal
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
030303
Country
Romania
Facility Name
GSK Investigational Site
City
Iasi
ZIP/Postal Code
700116
Country
Romania
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
GSK Investigational Site
City
Elche (Alicante)
ZIP/Postal Code
03202
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28047
Country
Spain
Facility Name
GSK Investigational Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
GSK Investigational Site
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
GSK Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
GSK Investigational Site
City
Tarrasa, Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
GSK Investigational Site
City
Vigo ( Pontevedra)
ZIP/Postal Code
36204
Country
Spain
Facility Name
GSK Investigational Site
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
GSK Investigational Site
City
Olten
ZIP/Postal Code
4600
Country
Switzerland
Facility Name
GSK Investigational Site
City
St Gallen
ZIP/Postal Code
9007
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
16890834
Citation
Eron J Jr, Yeni P, Gathe J Jr, Estrada V, DeJesus E, Staszewski S, Lackey P, Katlama C, Young B, Yau L, Sutherland-Phillips D, Wannamaker P, Vavro C, Patel L, Yeo J, Shaefer M; KLEAN study team. The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial. Lancet. 2006 Aug 5;368(9534):476-82. doi: 10.1016/S0140-6736(06)69155-1. Erratum In: Lancet. 2006 Oct 7;368(9543):1238.
Results Reference
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KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks

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