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
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Abbott |
United States, Australia, Belgium, Canada, Czech Republic, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Puerto Rico, Russian Federation, Singapore, Spain, Switzerland, Taiwan, United Kingdom,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03563742 -
A Study to Determine the Safety and Efficacy of Rilpivirine in Treatment-naive Indian Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection
|
Phase 3 | |
Completed |
NCT00294918 -
An Efficacy and Safety Trial of Serostim® in the Maintenance of the Treatment Effect Obtained During the Study of Serostim® in Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome
|
Phase 2/Phase 3 | |
Completed |
NCT00888446 -
Safety and Immunogenicity Study of tgAAC09, an HIV Vaccine in an Adeno-associated Virus (AAV) Capsid
|
Phase 2 | |
Completed |
NCT00294164 -
Safety and Efficacy Trial of Serostim® in the Treatment of Subjects With Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT00332306 -
Safety and Efficacy of Two Once Daily Anti Retroviral Treatment Regimens Along With Anti-tuberculosis Treatment
|
Phase 3 | |
Completed |
NCT00727597 -
A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT
|
Phase 3 | |
Completed |
NCT02452242 -
Safety, PK and PD Study of ABX464 in Untreated HIV Patients
|
Phase 2 | |
Active, not recruiting |
NCT00376012 -
Short Course Intermittent Regimens for the Treatment of HIV-Associated Tuberculosis
|
Phase 3 | |
Completed |
NCT00358917 -
Study of Lopinavir/Ritonavir Tablets Comparing Once-Daily Versus Twice-Daily Administration When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Experienced Human Immunodeficiency Virus Type 1 Infected Subjects
|
Phase 3 | |
Completed |
NCT00749840 -
Attitudes and Beliefs and the Steps of HIV Care
|
N/A |