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

NCT00262522 | Completed Phase 3 Results

• 2 other identifiers: M05-7302005-001430-32
• Study Type: interventional
• Target: 664
• Locations: 19 countries
• Sites: 129

Brief Summary

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.

Conditions

Human Immunodeficiency Virus Infections

Keywords

Human Immunodeficiency Virus Infections

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks

  Week 8

• Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48

  Week 48

Secondary Outcomes (2)

• Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96

  Week 96 (End of Study)

• Mean Change From Baseline to Week 96 in CD4+ T Cell Counts

  Week 96 (End of Study)

Study Arms (4)

LPV/r 800/200 mg QD Tablet

EXPERIMENTAL

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

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

EXPERIMENTAL

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

LPV/r 400/100 mg BID Tablet

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

Interventions

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

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

Also known as: ABT-378, Kaletra, lopinavir/ritonavir

LPV/r 800/200 mg QD Tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (129)

Site Reference ID/Investigator# 823

Phoenix, Arizona, 85006, United States

Location

Site Reference ID/Investigator# 846

Phoenix, Arizona, 85012, United States

Location

Site Reference ID/Investigator# 851

Beverly Hills, California, 90211, United States

Location

Site Reference ID/Investigator# 872

Fountain Valley, California, 92708, United States

Location

Site Reference ID/Investigator# 826

Long Beach, California, 90813, United States

Location

Site Reference ID/Investigator# 876

Newport Beach, California, 92663, United States

Location

Site Reference ID/Investigator# 875

Washington D.C., District of Columbia, 20037, United States

Location

Site Reference ID/Investigator# 870

Atlantis, Florida, 33462, United States

Location

Site Reference ID/Investigator# 844

Fort Lauderdale, Florida, 33311, United States

Location

Site Reference ID/Investigator# 874

Miami, Florida, 33136, United States

Location

Site Reference ID/Investigator# 1153

Orlando, Florida, 32803, United States

Location

Site Reference ID/Investigator# 827

Orlando, Florida, 32803, United States

Location

Site Reference ID/Investigator# 783

Plantation, Florida, 33317, United States

Location

Site Reference ID/Investigator# 877

Port Saint Lucie, Florida, 34952, United States

Location

Site Reference ID/Investigator# 845

Safety Harbor, Florida, 34695, United States

Location

Site Reference ID/Investigator# 849

Sarasota, Florida, 34243, United States

Location

Site Reference ID/Investigator# 825

Tampa, Florida, 33614, United States

Location

Site Reference ID/Investigator# 848

Atlanta, Georgia, 30309, United States

Location

Site Reference ID/Investigator# 873

Macon, Georgia, 31201, United States

Location

Site Reference ID/Investigator# 1154

Chicago, Illinois, 60612, United States

Location

Site Reference ID/Investigator# 824

Chicago, Illinois, 60613, United States

Location

Site Reference ID/Investigator# 792

Wichita, Kansas, 67214, United States

Location

Site Reference ID/Investigator# 1157

Minneapolis, Minnesota, 55404, United States

Location

Site Reference ID/Investigator# 871

St Louis, Missouri, 63108, United States

Location

Site Reference ID/Investigator# 2450

Rochester, New York, 14620, United States

Location

Site Reference ID/Investigator# 784

Charlotte, North Carolina, 28209, United States

Location

Site Reference ID/Investigator# 1155

Dallas, Texas, 75208, United States

Location

Site Reference ID/Investigator# 850

Dallas, Texas, 75246, United States

Location

Site Reference ID/Investigator# 843

Houston, Texas, 77004, United States

Location

Site Reference ID/Investigator# 1156

Hampton, Virginia, 23666, United States

Location

Site Reference ID/Investigator# 244

Darlinghurst, 2010, Australia

Location

Site Reference ID/Investigator# 245

Melbourne, 3004, Australia

Location

Site Reference ID/Investigator# 246

South Yarra, 3141, Australia

Location

Site Reference ID/Investigator# 234

Antwerp, 2000, Belgium

Location

Site Reference ID/Investigator# 235

Brussels, 1200, Belgium

Location

Site Reference ID/Investigator# 233

Ghent, 9000, Belgium

Location

Site Reference ID/Investigator# 236

Leuven, 3000, Belgium

Location

Site Reference ID/Investigator# 225

Liège, 4000, Belgium

Location

Site Reference ID/Investigator# 175

Calgary, T2R 0X7, Canada

Location

Site Reference ID/Investigator# 184

Hamilton, L8N 3Z5, Canada

Location

Site Reference ID/Investigator# 177

Montreal, H2L 4P9, Canada

Location

Site Reference ID/Investigator# 176

Montreal, H2L 5B1, Canada

Location

Site Reference ID/Investigator# 179

Montreal, H2X 2P4, Canada

Location

Site Reference ID/Investigator# 181

Ottawa, K1H 8L6, Canada

Location

Site Reference ID/Investigator# 173

Ottawa, K1N 6N5, Canada

Location

Site Reference ID/Investigator# 178

Ste-Foy, G1V 4G2, Canada

Location

Site Reference ID/Investigator# 180

Toronto, M4N 3M5, Canada

Location

Site Reference ID/Investigator# 182

Toronto, M5B 1L6, Canada

Location

Site Reference ID/Investigator# 174

Toronto, M5G 2C4, Canada

Location

Site Reference ID/Investigator# 183

Vancouver, V6Z 2C7, Canada

Location

Site Reference ID/Investigator# 172

Vancouver, V6Z 2T1, Canada

Location

Site Reference ID/Investigator# 294

Brno, 639 00, Czechia

Location

Site Reference ID/Investigator# 296

Pilsen, 305 99, Czechia

Location

Site Reference ID/Investigator# 286

Aix-en-Provence, 13616, France

Location

Site Reference ID/Investigator# 275

Besançon, 25030, France

Location

Site Reference ID/Investigator# 256

Lyon, 69288, France

Location

Site Reference ID/Investigator# 278

Montpellier, 34295, France

Location

Site Reference ID/Investigator# 257

Paris, 75012, France

Location

Site Reference ID/Investigator# 281

Paris, 75014, France

Location

Site Reference ID/Investigator# 280

Paris, 75475, France

Location

Site Reference ID/Investigator# 279

Paris, 75877, France

Location

Site Reference ID/Investigator# 284

Paris, 75970, France

Location

Site Reference ID/Investigator# 274

Rennes, 35033, France

Location

Site Reference ID/Investigator# 282

Vandœuvre-lès-Nancy, 54511, France

Location

Site Reference ID/Investigator# 265

Berlin, 13353, Germany

Location

Site Reference ID/Investigator# 270

Berlin, D-10243, Germany

Location

Site Reference ID/Investigator# 262

Bochum, D-44791, Germany

Location

Site Reference ID/Investigator# 268

Bonn, 53127, Germany

Location

Site Reference ID/Investigator# 271

Cologne, 50931, Germany

Location

Site Reference ID/Investigator# 266

Frankfurt, 60590, Germany

Location

Site Reference ID/Investigator# 264

Fürth, D-90762, Germany

Location

Site Reference ID/Investigator# 273

Hamburg, 20146, Germany

Location

Site Reference ID/Investigator# 267

Hamburg, D-20099, Germany

Location

Site Reference ID/Investigator# 263

Hanover, 30159, Germany

Location

Site Reference ID/Investigator# 211

Athens, 115 26, Greece

Location

Site Reference ID/Investigator# 207

Thessaloniki, 54636, Greece

Location

Site Reference ID/Investigator# 237

Dublin, Ireland

Location

Site Reference ID/Investigator# 249

Dublin, Ireland

Location

Site Reference ID/Investigator# 203

Brescia, 25123, Italy

Location

Site Reference ID/Investigator# 192

Florence, 50011, Italy

Location

Site Reference ID/Investigator# 195

Genoa, 16132, Italy

Location

Site Reference ID/Investigator# 201

Milan, 20127, Italy

Location

Site Reference ID/Investigator# 198

Milan, 20157, Italy

Location

Site Reference ID/Investigator# 199

Pavia, 27100, Italy

Location

Site Reference ID/Investigator# 200

Rome, 00149, Italy

Location

Site Reference ID/Investigator# 196

Rome, 00161, Italy

Location

Site Reference ID/Investigator# 194

Rome, 00184, Italy

Location

Site Reference ID/Investigator# 193

Turin, 10149, Italy

Location

Site Reference ID/Investigator# 290

Zwolle, 8025 AB, Netherlands

Location

Site Reference ID/Investigator# 298

Chorzów, 41-500, Poland

Location

Site Reference ID/Investigator# 299

Warsaw, 01-201, Poland

Location

Site Reference ID/Investigator# 297

Wroclaw, 51-149, Poland

Location

Site Reference ID/Investigator# 185

Ponce, 00717-1563, Puerto Rico

Location

Site Reference ID/Investigator# 208

Ponce, 00731, Puerto Rico

Location

Site Reference ID/Investigator# 206

San Juan, 00936-5067, Puerto Rico

Location

Site Reference ID/Investigator# 186

Moscow, 105275, Russia

Location

Site Reference ID/Investigator# 189

Moscow, 105275, Russia

Location

Site Reference ID/Investigator# 188

Saint Petersburg, 190020, Russia

Location

Site Reference ID/Investigator# 5163

Singapore, 308433, Singapore

Location

Site Reference ID/Investigator# 221

A Coruña, 15006, Spain

Location

Site Reference ID/Investigator# 210

Alicante, 03010, Spain

Location

Site Reference ID/Investigator# 190

Barakaldo, 48903, Spain

Location

Site Reference ID/Investigator# 214

Barcelona, 08035, Spain

Location

Site Reference ID/Investigator# 216

Barcelona, 08041, Spain

Location

Site Reference ID/Investigator# 222

Barcelona, 08916, Spain

Location

Site Reference ID/Investigator# 224

Barcelona, 8036, Spain

Location

Site Reference ID/Investigator# 218

Barcelona, 8907, Spain

Location

Site Reference ID/Investigator# 292

Madrid, 28007, Spain

Location

Site Reference ID/Investigator# 205

Madrid, 28029, Spain

Location

Site Reference ID/Investigator# 191

Madrid, 28034, Spain

Location

Site Reference ID/Investigator# 219

Madrid, 28040, Spain

Location

Site Reference ID/Investigator# 209

Madrid, 28041, Spain

Location

Site Reference ID/Investigator# 223

Madrid, 28046, Spain

Location

Site Reference ID/Investigator# 213

Santander, 39008, Spain

Location

Site Reference ID/Investigator# 217

Santiago de Compostela, 15705, Spain

Location

Site Reference ID/Investigator# 220

Seville, 41013, Spain

Location

Site Reference ID/Investigator# 215

Valencia, 46009, Spain

Location

Site Reference ID/Investigator# 288

Basel, 4031, Switzerland

Location

Site Reference ID/Investigator# 289

Geneva, 1211, Switzerland

Location

Site Reference ID/Investigator# 243

Lausanne, 1011, Switzerland

Location

Site Reference ID/Investigator# 254

Sankt Gallen, 9007, Switzerland

Location

Site Reference ID/Investigator# 241

Taipei, 10016, Taiwan

Location

Site Reference ID/Investigator# 238

Birmingham, B9 5SS, United Kingdom

Location

Site Reference ID/Investigator# 232

Brighton, BN2 1ES, United Kingdom

Location

Site Reference ID/Investigator# 226

London, N18 1QX, United Kingdom

Location

Site Reference ID/Investigator# 231

London, NW3 2QG, United Kingdom

Location

Site Reference ID/Investigator# 227

London, SW17 0QT, United Kingdom

Location

Site Reference ID/Investigator# 228

London, W2 1NY, United Kingdom

Location

Site Reference ID/Investigator# 229

Manchester, M8 5RB, United Kingdom

Location

MeSH Terms

Interventions

Lopinavir; Ritonavir; Tablets; Capsules; lopinavir-ritonavir drug combination

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Study Officials

• Daniel E Cohen, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2005
• First Posted: December 7, 2005
• Study Start: November 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 6, 2012
• Results First Posted: August 20, 2009

Record last verified: 2012-02

Locations

BE (5); SG (1); RU (3); IT (10); GB (7); DE (10); US (30); PL (3); GR (2); IE (2); NL (1); FR (11); AU (3); CA (13); CH (4); TW (1); CZ (2); ES (18); PR (3)