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Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With Nucleoside Reverse Transcriptase Inhibitors in Antiretroviral Naive Human Immunodeficiency Virus Type 1 Infected Subjects

NCT ID: NCT00262522

Last Updated: 2012-02-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

664 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-07-31

Brief Summary

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The purpose of this study was to compare the safety and tolerability of the to-be-marketed lopinavir/ritonavir (LPV/r) tablet formulation with the marketed soft gel capsule (SGC) formulation and to compare the safety, tolerability, and antiviral activity of once daily (QD) and twice daily (BID) dosing of the LPV/r tablet formulation in combination with select nucleoside reverse transcriptase inhibitors (NRTIs) in patients who have not previously received antiretroviral treatment.

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Detailed Description

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Conditions

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Human Immunodeficiency Virus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LPV/r 800/200 mg QD Tablet

Group Type EXPERIMENTAL

lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

Intervention Type DRUG

LPV/r 800/200 mg once daily (QD) tablet + emtricitabine (FTC) 200 mg QD + tenofovir disoproxil fumarate (TDF) 300 mg QD

LPV/r 800/200 mg QD SGC (Through Week 8)

Group Type EXPERIMENTAL

lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

Intervention Type DRUG

LPV/r 800/200 mg QD soft gel capsule (SGC) + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 800/200 mg QD Tablet + FTC 200 mg QD + TDF 300 mg QD

LPV/r 400/100 mg BID Tablet

Group Type ACTIVE_COMPARATOR

lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

Intervention Type DRUG

LPV/r 400/100 mg twice daily (BID) tablet + FTC 200 mg QD + TDF 300 mg QD

LPV/r 400/100 mg BID SGC (Through Week 8)

Group Type ACTIVE_COMPARATOR

lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

Intervention Type DRUG

LPV/r 400/100 mg BID SGC + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 400/100 mg BID Tablet + FTC 200 mg QD + TDF 300 mg QD

Interventions

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lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

LPV/r 800/200 mg once daily (QD) tablet + emtricitabine (FTC) 200 mg QD + tenofovir disoproxil fumarate (TDF) 300 mg QD

Intervention Type DRUG

lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

LPV/r 800/200 mg QD soft gel capsule (SGC) + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 800/200 mg QD Tablet + FTC 200 mg QD + TDF 300 mg QD

Intervention Type DRUG

lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

LPV/r 400/100 mg twice daily (BID) tablet + FTC 200 mg QD + TDF 300 mg QD

Intervention Type DRUG

lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

LPV/r 400/100 mg BID SGC + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 400/100 mg BID Tablet + FTC 200 mg QD + TDF 300 mg QD

Intervention Type DRUG

Other Intervention Names

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ABT-378, Kaletra, lopinavir/ritonavir ABT-378, Kaletra, lopinavir/ritonavir ABT-378, Kaletra, lopinavir/ritonavir ABT-378, Kaletra, lopinavir/ritonavir

Eligibility Criteria

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Inclusion Criteria

* Subjects were human immunodeficiency virus type 1 (HIV-1) positive, antiretroviral naïve adults at least 18 years of age with \< 7 days of prior antiretroviral therapy.
* Subjects had plasma HIV-1 ribonucleic acid (RNA) levels \>= 1,000 copies/mL at screening and were not acutely ill.
* Female subjects were nonpregnant and nonlactating.

Exclusion Criteria

* Subjects were excluded if screening laboratory analyses showed any of the following abnormal laboratory results:

* Presence of hepatitis B surface antigen (HBsAg)
* Hemoglobin \<= 8.0 g/dL
* Absolute neutrophil count \<= 750 cells/microliter
* Platelet count \<= 50,000 per mL
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>= 3.0 x Upper Limit of Normal (ULN)
* Calculated creatinine clearance \< 50 mL/min
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel E Cohen, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Reference ID/Investigator# 823

Phoenix, Arizona, United States

Site Status

Site Reference ID/Investigator# 846

Phoenix, Arizona, United States

Site Status

Site Reference ID/Investigator# 851

Beverly Hills, California, United States

Site Status

Site Reference ID/Investigator# 872

Fountain Valley, California, United States

Site Status

Site Reference ID/Investigator# 826

Long Beach, California, United States

Site Status

Site Reference ID/Investigator# 876

Newport Beach, California, United States

Site Status

Site Reference ID/Investigator# 875

Washington D.C., District of Columbia, United States

Site Status

Site Reference ID/Investigator# 870

Atlantis, Florida, United States

Site Status

Site Reference ID/Investigator# 844

Fort Lauderdale, Florida, United States

Site Status

Site Reference ID/Investigator# 874

Miami, Florida, United States

Site Status

Site Reference ID/Investigator# 1153

Orlando, Florida, United States

Site Status

Site Reference ID/Investigator# 827

Orlando, Florida, United States

Site Status

Site Reference ID/Investigator# 783

Plantation, Florida, United States

Site Status

Site Reference ID/Investigator# 877

Port Saint Lucie, Florida, United States

Site Status

Site Reference ID/Investigator# 845

Safety Harbor, Florida, United States

Site Status

Site Reference ID/Investigator# 849

Sarasota, Florida, United States

Site Status

Site Reference ID/Investigator# 825

Tampa, Florida, United States

Site Status

Site Reference ID/Investigator# 848

Atlanta, Georgia, United States

Site Status

Site Reference ID/Investigator# 873

Macon, Georgia, United States

Site Status

Site Reference ID/Investigator# 1154

Chicago, Illinois, United States

Site Status

Site Reference ID/Investigator# 824

Chicago, Illinois, United States

Site Status

Site Reference ID/Investigator# 792

Wichita, Kansas, United States

Site Status

Site Reference ID/Investigator# 1157

Minneapolis, Minnesota, United States

Site Status

Site Reference ID/Investigator# 871

St Louis, Missouri, United States

Site Status

Site Reference ID/Investigator# 2450

Rochester, New York, United States

Site Status

Site Reference ID/Investigator# 784

Charlotte, North Carolina, United States

Site Status

Site Reference ID/Investigator# 1155

Dallas, Texas, United States

Site Status

Site Reference ID/Investigator# 850

Dallas, Texas, United States

Site Status

Site Reference ID/Investigator# 843

Houston, Texas, United States

Site Status

Site Reference ID/Investigator# 1156

Hampton, Virginia, United States

Site Status

Site Reference ID/Investigator# 244

Darlinghurst, , Australia

Site Status

Site Reference ID/Investigator# 245

Melbourne, , Australia

Site Status

Site Reference ID/Investigator# 246

South Yarra, , Australia

Site Status

Site Reference ID/Investigator# 234

Antwerp, , Belgium

Site Status

Site Reference ID/Investigator# 235

Brussels, , Belgium

Site Status

Site Reference ID/Investigator# 233

Ghent, , Belgium

Site Status

Site Reference ID/Investigator# 236

Leuven, , Belgium

Site Status

Site Reference ID/Investigator# 225

Liège, , Belgium

Site Status

Site Reference ID/Investigator# 175

Calgary, , Canada

Site Status

Site Reference ID/Investigator# 184

Hamilton, , Canada

Site Status

Site Reference ID/Investigator# 177

Montreal, , Canada

Site Status

Site Reference ID/Investigator# 176

Montreal, , Canada

Site Status

Site Reference ID/Investigator# 179

Montreal, , Canada

Site Status

Site Reference ID/Investigator# 181

Ottawa, , Canada

Site Status

Site Reference ID/Investigator# 173

Ottawa, , Canada

Site Status

Site Reference ID/Investigator# 178

Ste-Foy, , Canada

Site Status

Site Reference ID/Investigator# 180

Toronto, , Canada

Site Status

Site Reference ID/Investigator# 182

Toronto, , Canada

Site Status

Site Reference ID/Investigator# 174

Toronto, , Canada

Site Status

Site Reference ID/Investigator# 183

Vancouver, , Canada

Site Status

Site Reference ID/Investigator# 172

Vancouver, , Canada

Site Status

Site Reference ID/Investigator# 294

Brno, , Czechia

Site Status

Site Reference ID/Investigator# 296

Pilsen, , Czechia

Site Status

Site Reference ID/Investigator# 286

Aix-en-Provence, , France

Site Status

Site Reference ID/Investigator# 275

Besançon, , France

Site Status

Site Reference ID/Investigator# 256

Lyon, , France

Site Status

Site Reference ID/Investigator# 278

Montpellier, , France

Site Status

Site Reference ID/Investigator# 257

Paris, , France

Site Status

Site Reference ID/Investigator# 281

Paris, , France

Site Status

Site Reference ID/Investigator# 280

Paris, , France

Site Status

Site Reference ID/Investigator# 279

Paris, , France

Site Status

Site Reference ID/Investigator# 284

Paris, , France

Site Status

Site Reference ID/Investigator# 274

Rennes, , France

Site Status

Site Reference ID/Investigator# 282

Vandœuvre-lès-Nancy, , France

Site Status

Site Reference ID/Investigator# 265

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 270

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 262

Bochum, , Germany

Site Status

Site Reference ID/Investigator# 268

Bonn, , Germany

Site Status

Site Reference ID/Investigator# 271

Cologne, , Germany

Site Status

Site Reference ID/Investigator# 266

Frankfurt, , Germany

Site Status

Site Reference ID/Investigator# 264

Fürth, , Germany

Site Status

Site Reference ID/Investigator# 273

Hamburg, , Germany

Site Status

Site Reference ID/Investigator# 267

Hamburg, , Germany

Site Status

Site Reference ID/Investigator# 263

Hanover, , Germany

Site Status

Site Reference ID/Investigator# 211

Athens, , Greece

Site Status

Site Reference ID/Investigator# 207

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 237

Dublin, , Ireland

Site Status

Site Reference ID/Investigator# 249

Dublin, , Ireland

Site Status

Site Reference ID/Investigator# 203

Brescia, , Italy

Site Status

Site Reference ID/Investigator# 192

Florence, , Italy

Site Status

Site Reference ID/Investigator# 195

Genoa, , Italy

Site Status

Site Reference ID/Investigator# 201

Milan, , Italy

Site Status

Site Reference ID/Investigator# 198

Milan, , Italy

Site Status

Site Reference ID/Investigator# 199

Pavia, , Italy

Site Status

Site Reference ID/Investigator# 200

Rome, , Italy

Site Status

Site Reference ID/Investigator# 196

Rome, , Italy

Site Status

Site Reference ID/Investigator# 194

Rome, , Italy

Site Status

Site Reference ID/Investigator# 193

Turin, , Italy

Site Status

Site Reference ID/Investigator# 290

Zwolle, , Netherlands

Site Status

Site Reference ID/Investigator# 298

Chorzów, , Poland

Site Status

Site Reference ID/Investigator# 299

Warsaw, , Poland

Site Status

Site Reference ID/Investigator# 297

Wroclaw, , Poland

Site Status

Site Reference ID/Investigator# 185

Ponce, , Puerto Rico

Site Status

Site Reference ID/Investigator# 208

Ponce, , Puerto Rico

Site Status

Site Reference ID/Investigator# 206

San Juan, , Puerto Rico

Site Status

Site Reference ID/Investigator# 186

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 189

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 188

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 5163

Singapore, , Singapore

Site Status

Site Reference ID/Investigator# 221

A Coruña, , Spain

Site Status

Site Reference ID/Investigator# 210

Alicante, , Spain

Site Status

Site Reference ID/Investigator# 190

Barakaldo, , Spain

Site Status

Site Reference ID/Investigator# 214

Barcelona, , Spain

Site Status

Site Reference ID/Investigator# 216

Barcelona, , Spain

Site Status

Site Reference ID/Investigator# 222

Barcelona, , Spain

Site Status

Site Reference ID/Investigator# 224

Barcelona, , Spain

Site Status

Site Reference ID/Investigator# 218

Barcelona, , Spain

Site Status

Site Reference ID/Investigator# 292

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 205

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 191

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 219

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 209

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 223

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 213

Santander, , Spain

Site Status

Site Reference ID/Investigator# 217

Santiago de Compostela, , Spain

Site Status

Site Reference ID/Investigator# 220

Seville, , Spain

Site Status

Site Reference ID/Investigator# 215

Valencia, , Spain

Site Status

Site Reference ID/Investigator# 288

Basel, , Switzerland

Site Status

Site Reference ID/Investigator# 289

Geneva, , Switzerland

Site Status

Site Reference ID/Investigator# 243

Lausanne, , Switzerland

Site Status

Site Reference ID/Investigator# 254

Sankt Gallen, , Switzerland

Site Status

Site Reference ID/Investigator# 241

Taipei, , Taiwan

Site Status

Site Reference ID/Investigator# 238

Birmingham, , United Kingdom

Site Status

Site Reference ID/Investigator# 232

Brighton, , United Kingdom

Site Status

Site Reference ID/Investigator# 226

London, , United Kingdom

Site Status

Site Reference ID/Investigator# 231

London, , United Kingdom

Site Status

Site Reference ID/Investigator# 227

London, , United Kingdom

Site Status

Site Reference ID/Investigator# 228

London, , United Kingdom

Site Status

Site Reference ID/Investigator# 229

Manchester, , United Kingdom

Site Status

Countries

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United States Australia Belgium Canada Czechia France Germany Greece Ireland Italy Netherlands Poland Puerto Rico Russia Singapore Spain Switzerland Taiwan United Kingdom

Other Identifiers

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2005-001430-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M05-730

Identifier Type: -

Identifier Source: org_study_id

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