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NCT00262522 Clinical Trial

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

Human Immunodeficiency Virus Infections Clinical Trial

Official title:
A Phase 3, Randomized, Open-label, Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With NRTIs in Antiretroviral Naive HIV-1 Infected Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00262522
Other study ID # M05-730
Secondary ID 2005-001430-32
Status Completed
Phase Phase 3
First received December 5, 2005
Last updated February 3, 2012
Start date November 2005
Est. completion date July 2008

Study information
Verified date February 2012
Source Abbott
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Ministry of Social Affairs, Public Health and the EnvironmentCanada: Health CanadaCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesIreland: Irish Medicines BoardItaly: The Italian Medicines AgencyNetherlands: Medicines Evaluation Board (MEB)Poland: Ministry of HealthRussia: Ministry of Health of the Russian FederationSingapore: Health Sciences AuthoritySpain: Spanish Agency of MedicinesSwitzerland: SwissmedicTaiwan : Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 664
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 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
• 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
• 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
• 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

Locations
Country Name City State
Australia Site Reference ID/Investigator# 244 Darlinghurst
Australia Site Reference ID/Investigator# 245 Melbourne
Australia Site Reference ID/Investigator# 246 South Yarra
Belgium Site Reference ID/Investigator# 234 Antwerp
Belgium Site Reference ID/Investigator# 235 Brussels
Belgium Site Reference ID/Investigator# 233 Ghent
Belgium Site Reference ID/Investigator# 236 Leuven
Belgium Site Reference ID/Investigator# 225 Liege 1
Canada Site Reference ID/Investigator# 175 Calgary
Canada Site Reference ID/Investigator# 184 Hamilton
Canada Site Reference ID/Investigator# 176 Montreal
Canada Site Reference ID/Investigator# 177 Montreal
Canada Site Reference ID/Investigator# 179 Montreal
Canada Site Reference ID/Investigator# 173 Ottawa
Canada Site Reference ID/Investigator# 181 Ottawa
Canada Site Reference ID/Investigator# 178 Ste-Foy
Canada Site Reference ID/Investigator# 174 Toronto
Canada Site Reference ID/Investigator# 180 Toronto
Canada Site Reference ID/Investigator# 182 Toronto
Canada Site Reference ID/Investigator# 172 Vancouver
Canada Site Reference ID/Investigator# 183 Vancouver
Czech Republic Site Reference ID/Investigator# 294 Brno
Czech Republic Site Reference ID/Investigator# 296 Plzen
France Site Reference ID/Investigator# 286 Aix en Provence
France Site Reference ID/Investigator# 275 Besancon
France Site Reference ID/Investigator# 256 Lyon
France Site Reference ID/Investigator# 278 Montpellier Cedex 5
France Site Reference ID/Investigator# 257 Paris
France Site Reference ID/Investigator# 279 Paris
France Site Reference ID/Investigator# 280 Paris
France Site Reference ID/Investigator# 281 Paris
France Site Reference ID/Investigator# 284 Paris
France Site Reference ID/Investigator# 274 Rennes
France Site Reference ID/Investigator# 282 Vandoeuvre les Nancy
Germany Site Reference ID/Investigator# 265 Berlin
Germany Site Reference ID/Investigator# 270 Berlin
Germany Site Reference ID/Investigator# 262 Bochum
Germany Site Reference ID/Investigator# 268 Bonn
Germany Site Reference ID/Investigator# 271 Cologne
Germany Site Reference ID/Investigator# 266 Frankfurt
Germany Site Reference ID/Investigator# 264 Fuerth
Germany Site Reference ID/Investigator# 267 Hamburg
Germany Site Reference ID/Investigator# 273 Hamburg
Germany Site Reference ID/Investigator# 263 Hannover
Greece Site Reference ID/Investigator# 211 Athens
Greece Site Reference ID/Investigator# 207 Thessaloniki
Ireland Site Reference ID/Investigator# 249 Dublin 7
Ireland Site Reference ID/Investigator# 237 Dublin 8
Italy Site Reference ID/Investigator# 203 Brescia
Italy Site Reference ID/Investigator# 192 Florence
Italy Site Reference ID/Investigator# 195 Genoa
Italy Site Reference ID/Investigator# 198 Milan
Italy Site Reference ID/Investigator# 201 Milan
Italy Site Reference ID/Investigator# 199 Pavia
Italy Site Reference ID/Investigator# 194 Rome
Italy Site Reference ID/Investigator# 196 Rome
Italy Site Reference ID/Investigator# 200 Rome
Italy Site Reference ID/Investigator# 193 Turin
Netherlands Site Reference ID/Investigator# 290 Zwolle
Poland Site Reference ID/Investigator# 298 Chorzow
Poland Site Reference ID/Investigator# 299 Warsaw
Poland Site Reference ID/Investigator# 297 Wroclaw
Puerto Rico Site Reference ID/Investigator# 185 Ponce
Puerto Rico Site Reference ID/Investigator# 208 Ponce
Puerto Rico Site Reference ID/Investigator# 206 San Juan
Russian Federation Site Reference ID/Investigator# 186 Moscow
Russian Federation Site Reference ID/Investigator# 189 Moscow
Russian Federation Site Reference ID/Investigator# 188 St. Petersburg
Singapore Site Reference ID/Investigator# 5163 Singapore
Spain Site Reference ID/Investigator# 221 A Coruna
Spain Site Reference ID/Investigator# 210 Alicante
Spain Site Reference ID/Investigator# 190 Barakaldo
Spain Site Reference ID/Investigator# 214 Barcelona
Spain Site Reference ID/Investigator# 216 Barcelona
Spain Site Reference ID/Investigator# 218 Barcelona
Spain Site Reference ID/Investigator# 222 Barcelona
Spain Site Reference ID/Investigator# 224 Barcelona
Spain Site Reference ID/Investigator# 191 Madrid
Spain Site Reference ID/Investigator# 205 Madrid
Spain Site Reference ID/Investigator# 209 Madrid
Spain Site Reference ID/Investigator# 219 Madrid
Spain Site Reference ID/Investigator# 223 Madrid
Spain Site Reference ID/Investigator# 292 Madrid
Spain Site Reference ID/Investigator# 213 Santander
Spain Site Reference ID/Investigator# 217 Santiago de Compostela
Spain Site Reference ID/Investigator# 220 Seville
Spain Site Reference ID/Investigator# 215 Valencia
Switzerland Site Reference ID/Investigator# 288 Basel
Switzerland Site Reference ID/Investigator# 289 Geneva 14
Switzerland Site Reference ID/Investigator# 243 Lausanne
Switzerland Site Reference ID/Investigator# 254 St. Gallen
Taiwan Site Reference ID/Investigator# 241 Taipei City
United Kingdom Site Reference ID/Investigator# 238 Birmingham
United Kingdom Site Reference ID/Investigator# 232 Brighton
United Kingdom Site Reference ID/Investigator# 226 London
United Kingdom Site Reference ID/Investigator# 227 London
United Kingdom Site Reference ID/Investigator# 228 London
United Kingdom Site Reference ID/Investigator# 231 London
United Kingdom Site Reference ID/Investigator# 229 Manchester
United States Site Reference ID/Investigator# 848 Atlanta Georgia
United States Site Reference ID/Investigator# 870 Atlantis Florida
United States Site Reference ID/Investigator# 851 Beverly Hills California
United States Site Reference ID/Investigator# 784 Charlotte North Carolina
United States Site Reference ID/Investigator# 1154 Chicago Illinois
United States Site Reference ID/Investigator# 824 Chicago Illinois
United States Site Reference ID/Investigator# 1155 Dallas Texas
United States Site Reference ID/Investigator# 850 Dallas Texas
United States Site Reference ID/Investigator# 844 Fort Lauderdale Florida
United States Site Reference ID/Investigator# 872 Fountain Valley California
United States Site Reference ID/Investigator# 1156 Hampton Virginia
United States Site Reference ID/Investigator# 843 Houston Texas
United States Site Reference ID/Investigator# 826 Long Beach California
United States Site Reference ID/Investigator# 873 Macon Georgia
United States Site Reference ID/Investigator# 874 Miami Florida
United States Site Reference ID/Investigator# 1157 Minneapolis Minnesota
United States Site Reference ID/Investigator# 876 Newport Beach California
United States Site Reference ID/Investigator# 1153 Orlando Florida
United States Site Reference ID/Investigator# 827 Orlando Florida
United States Site Reference ID/Investigator# 823 Phoenix Arizona
United States Site Reference ID/Investigator# 846 Phoenix Arizona
United States Site Reference ID/Investigator# 783 Plantation Florida
United States Site Reference ID/Investigator# 877 Port Saint Lucie Florida
United States Site Reference ID/Investigator# 2450 Rochester New York
United States Site Reference ID/Investigator# 845 Safety Harbor Florida
United States Site Reference ID/Investigator# 849 Sarasota Florida
United States Site Reference ID/Investigator# 871 St. Louis Missouri
United States Site Reference ID/Investigator# 825 Tampa Florida
United States Site Reference ID/Investigator# 875 Washington District of Columbia
United States Site Reference ID/Investigator# 792 Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czech Republic,  France,  Germany,  Greece,  Ireland,  Italy,  Netherlands,  Poland,  Puerto Rico,  Russian Federation,  Singapore,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks Week 8 Yes
Primary Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48 Week 48 No
Secondary 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) No
Secondary Mean Change From Baseline to Week 96 in CD4+ T Cell Counts Week 96 (End of Study) No
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