Human Immunodeficiency Virus InfectionsPhase 3NCT00262522

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

A Phase 3 study testing lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs) in people with Human Immunodeficiency Virus Infections, run by Abbott at 129 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Human Immunodeficiency Virus Infections
What is being tested?: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 664 participants
Where: 129 sitesin 19 countries
Study dates: Nov 2005to Jul 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

129 sites in 19 countries.

Country

City, postcode or hospital

129 sites in 19 countries

United States30 sites

Site Reference ID/Investigator# 848
Atlanta, Georgia, 30309
Site Reference ID/Investigator# 870
Atlantis, Florida, 33462
Site Reference ID/Investigator# 851
Beverly Hills, California, 90211
Site Reference ID/Investigator# 784
Charlotte, North Carolina, 28209
Site Reference ID/Investigator# 1154
Chicago, Illinois, 60612
Site Reference ID/Investigator# 824
Chicago, Illinois, 60613
Site Reference ID/Investigator# 1155
Dallas, Texas, 75208
Site Reference ID/Investigator# 850
Dallas, Texas, 75246
Site Reference ID/Investigator# 844
Fort Lauderdale, Florida, 33311
Site Reference ID/Investigator# 872
Fountain Valley, California, 92708
Site Reference ID/Investigator# 1156
Hampton, Virginia, 23666
Site Reference ID/Investigator# 843
Houston, Texas, 77004
Site Reference ID/Investigator# 826
Long Beach, California, 90813
Site Reference ID/Investigator# 873
Macon, Georgia, 31201
Site Reference ID/Investigator# 874
Miami, Florida, 33136
Site Reference ID/Investigator# 1157
Minneapolis, Minnesota, 55404
Site Reference ID/Investigator# 876
Newport Beach, California, 92663
Site Reference ID/Investigator# 1153
Orlando, Florida, 32803
Site Reference ID/Investigator# 827
Orlando, Florida, 32803
Site Reference ID/Investigator# 823
Phoenix, Arizona, 85006
Site Reference ID/Investigator# 846
Phoenix, Arizona, 85012
Site Reference ID/Investigator# 783
Plantation, Florida, 33317
Site Reference ID/Investigator# 877
Port Saint Lucie, Florida, 34952
Site Reference ID/Investigator# 2450
Rochester, New York, 14620
Site Reference ID/Investigator# 845
Safety Harbor, Florida, 34695
Site Reference ID/Investigator# 849
Sarasota, Florida, 34243
Site Reference ID/Investigator# 871
St Louis, Missouri, 63108
Site Reference ID/Investigator# 825
Tampa, Florida, 33614
Site Reference ID/Investigator# 875
Washington D.C., District of Columbia, 20037
Site Reference ID/Investigator# 792
Wichita, Kansas, 67214

Other trials in United States

Spain18 sites

Site Reference ID/Investigator# 221
A Coruña, 15006
Site Reference ID/Investigator# 210
Alicante, 03010
Site Reference ID/Investigator# 190
Barakaldo, 48903
Site Reference ID/Investigator# 214
Barcelona, 08035
Site Reference ID/Investigator# 216
Barcelona, 08041
Site Reference ID/Investigator# 222
Barcelona, 08916
Site Reference ID/Investigator# 224
Barcelona, 8036
Site Reference ID/Investigator# 218
Barcelona, 8907
Site Reference ID/Investigator# 292
Madrid, 28007
Site Reference ID/Investigator# 205
Madrid, 28029
Site Reference ID/Investigator# 191
Madrid, 28034
Site Reference ID/Investigator# 219
Madrid, 28040
Site Reference ID/Investigator# 209
Madrid, 28041
Site Reference ID/Investigator# 223
Madrid, 28046
Site Reference ID/Investigator# 213
Santander, 39008
Site Reference ID/Investigator# 217
Santiago de Compostela, 15705
Site Reference ID/Investigator# 220
Seville, 41013
Site Reference ID/Investigator# 215
Valencia, 46009

Other trials in Spain

Canada13 sites

Site Reference ID/Investigator# 175
Calgary, T2R 0X7
Site Reference ID/Investigator# 184
Hamilton, L8N 3Z5
Site Reference ID/Investigator# 177
Montreal, H2L 4P9
Site Reference ID/Investigator# 176
Montreal, H2L 5B1
Site Reference ID/Investigator# 179
Montreal, H2X 2P4
Site Reference ID/Investigator# 181
Ottawa, K1H 8L6
Site Reference ID/Investigator# 173
Ottawa, K1N 6N5
Site Reference ID/Investigator# 178
Ste-Foy, G1V 4G2
Site Reference ID/Investigator# 180
Toronto, M4N 3M5
Site Reference ID/Investigator# 182
Toronto, M5B 1L6
Site Reference ID/Investigator# 174
Toronto, M5G 2C4
Site Reference ID/Investigator# 183
Vancouver, V6Z 2C7
Site Reference ID/Investigator# 172
Vancouver, V6Z 2T1

Other trials in Canada

France11 sites

Site Reference ID/Investigator# 286
Aix-en-Provence, 13616
Site Reference ID/Investigator# 275
Besançon, 25030
Site Reference ID/Investigator# 256
Lyon, 69288
Site Reference ID/Investigator# 278
Montpellier, 34295
Site Reference ID/Investigator# 257
Paris, 75012
Site Reference ID/Investigator# 281
Paris, 75014
Site Reference ID/Investigator# 280
Paris, 75475
Site Reference ID/Investigator# 279
Paris, 75877
Site Reference ID/Investigator# 284
Paris, 75970
Site Reference ID/Investigator# 274
Rennes, 35033
Site Reference ID/Investigator# 282
Vandœuvre-lès-Nancy, 54511

Other trials in France

Germany10 sites

Site Reference ID/Investigator# 265
Berlin, 13353
Site Reference ID/Investigator# 270
Berlin, D-10243
Site Reference ID/Investigator# 262
Bochum, D-44791
Site Reference ID/Investigator# 268
Bonn, 53127
Site Reference ID/Investigator# 271
Cologne, 50931
Site Reference ID/Investigator# 266
Frankfurt, 60590
Site Reference ID/Investigator# 264
Fürth, D-90762
Site Reference ID/Investigator# 273
Hamburg, 20146
Site Reference ID/Investigator# 267
Hamburg, D-20099
Site Reference ID/Investigator# 263
Hanover, 30159

Other trials in Germany

Italy10 sites

Site Reference ID/Investigator# 203
Brescia, 25123
Site Reference ID/Investigator# 192
Florence, 50011
Site Reference ID/Investigator# 195
Genoa, 16132
Site Reference ID/Investigator# 201
Milan, 20127
Site Reference ID/Investigator# 198
Milan, 20157
Site Reference ID/Investigator# 199
Pavia, 27100
Site Reference ID/Investigator# 200
Rome, 00149
Site Reference ID/Investigator# 196
Rome, 00161
Site Reference ID/Investigator# 194
Rome, 00184
Site Reference ID/Investigator# 193
Turin, 10149

Other trials in Italy

United Kingdom7 sites

Site Reference ID/Investigator# 238
Birmingham, B9 5SS
Site Reference ID/Investigator# 232
Brighton, BN2 1ES
Site Reference ID/Investigator# 226
London, N18 1QX
Site Reference ID/Investigator# 231
London, NW3 2QG
Site Reference ID/Investigator# 227
London, SW17 0QT
Site Reference ID/Investigator# 228
London, W2 1NY
Site Reference ID/Investigator# 229
Manchester, M8 5RB

Other trials in United Kingdom

Belgium5 sites

Site Reference ID/Investigator# 234
Antwerp, 2000
Site Reference ID/Investigator# 235
Brussels, 1200
Site Reference ID/Investigator# 233
Ghent, 9000
Site Reference ID/Investigator# 236
Leuven, 3000
Site Reference ID/Investigator# 225
Liège, 4000

Other trials in Belgium

Switzerland4 sites

Site Reference ID/Investigator# 288
Basel, 4031
Site Reference ID/Investigator# 289
Geneva, 1211
Site Reference ID/Investigator# 243
Lausanne, 1011
Site Reference ID/Investigator# 254
Sankt Gallen, 9007

Other trials in Switzerland

Australia3 sites

Site Reference ID/Investigator# 244
Darlinghurst, 2010
Site Reference ID/Investigator# 245
Melbourne, 3004
Site Reference ID/Investigator# 246
South Yarra, 3141

Other trials in Australia

Poland3 sites

Site Reference ID/Investigator# 298
Chorzów, 41-500
Site Reference ID/Investigator# 299
Warsaw, 01-201
Site Reference ID/Investigator# 297
Wroclaw, 51-149

Other trials in Poland

Puerto Rico3 sites

Site Reference ID/Investigator# 185
Ponce, 00717-1563
Site Reference ID/Investigator# 208
Ponce, 00731
Site Reference ID/Investigator# 206
San Juan, 00936-5067

Other trials in Puerto Rico

Russia3 sites

Site Reference ID/Investigator# 186
Moscow, 105275
Site Reference ID/Investigator# 189
Moscow, 105275
Site Reference ID/Investigator# 188
Saint Petersburg, 190020

Other trials in Russia

Czechia2 sites

Site Reference ID/Investigator# 294
Brno, 639 00
Site Reference ID/Investigator# 296
Pilsen, 305 99

Other trials in Czechia

Greece2 sites

Site Reference ID/Investigator# 211
Athens, 115 26
Site Reference ID/Investigator# 207
Thessaloniki, 54636

Other trials in Greece

Ireland2 sites

Site Reference ID/Investigator# 237
Dublin
Site Reference ID/Investigator# 249
Dublin

Other trials in Ireland

Netherlands1 site

Site Reference ID/Investigator# 290
Zwolle, 8025 AB

Other trials in Netherlands

Singapore1 site

Site Reference ID/Investigator# 5163
Singapore, 308433

Other trials in Singapore

Taiwan1 site

Site Reference ID/Investigator# 241
Taipei, 10016

Other trials in Taiwan

About this study

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

Conditions: Human Immunodeficiency Virus Infections
Being tested: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
Keywords: Human Immunodeficiency Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)Drug
Also called ABT-378, Kaletra, lopinavir/ritonavir
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)Drug
Also called ABT-378, Kaletra, lopinavir/ritonavir
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)Drug
Also called ABT-378, Kaletra, lopinavir/ritonavir
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)Drug
Also called ABT-378, Kaletra, lopinavir/ritonavir
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

Study groups in NCT00262522
Study group	Role	What they receive
LPV/r 800/200 mg QD Tablet	Experimental	Not described Receives: 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	Not described Receives: Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
LPV/r 400/100 mg BID Tablet	Active comparator	Not described Receives: 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	Not described Receives: Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks
Measured: Week 8
Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48
Measured: 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
Measured: Week 96 (End of Study)
Mean Change From Baseline to Week 96 in CD4+ T Cell Counts
Measured: Week 96 (End of Study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2005Jul 2008

First posted7 Dec 2005 (estimated)
Study startNov 2005
Primary completionJul 2008
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Human Immunodeficiency Virus InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 664 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00262522
Sponsor's protocol ID: M05-730
Other IDs: 2005-001430-32, 2005
Status last verified: Feb 2012
First submitted: 5 Dec 2005
Last updated: 6 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI

All Human Immunodeficiency Virus Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00262522
Acronym / sponsor ID: M05-730
Conditions: Human Immunodeficiency Virus Infections
Keywords: Human Immunodeficiency Virus Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 664 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Nov 2005
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 7 Dec 2005 (estimated)
Results: Posted 20 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
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)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)Also: ABT-378, Kaletra, lopinavir/ritonavirLPV/r 800/200 mg once daily (QD) tablet + emtricitabine (FTC) 200 mg QD + tenofovir disoproxil fumarate (TDF) 300 mg QD	Drug	LPV/r 800/200 mg QD Tablet
lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)Also: ABT-378, Kaletra, lopinavir/ritonavirLPV/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	Drug	LPV/r 800/200 mg QD SGC (Through Week 8)
lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)Also: ABT-378, Kaletra, lopinavir/ritonavirLPV/r 400/100 mg twice daily (BID) tablet + FTC 200 mg QD + TDF 300 mg QD	Drug	LPV/r 400/100 mg BID Tablet
lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)Also: ABT-378, Kaletra, lopinavir/ritonavirLPV/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	Drug	LPV/r 400/100 mg BID SGC (Through Week 8)

Primary outcome

Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks
Time frame: Week 8
Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48
Time frame: Week 48

2 secondary outcomes

Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96
Time frame: Week 96 (End of Study)
Mean Change From Baseline to Week 96 in CD4+ T Cell Counts
Time frame: Week 96 (End of Study)

Results and safety

Results posted to the registry on 20 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LPV/r 800/200 mg QD Tablet	167	163
LPV/r 800/200 mg QD SGC (Through Week 8)	166	161
LPV/r 400/100 mg BID Tablet	166	155
LPV/r 400/100 mg BID SGC (Through Week 8)	165	160

Primary outcome: Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks

Time frame: Week 8. Number. Unit: Percentage of Subjects

Measure	LPV/r 800/200 mg QD Tablet n = 167	LPV/r 800/200 mg QD SGC (Through Week 8) n = 166	LPV/r 400/100 mg BID Tablet n = 166	LPV/r 400/100 mg BID SGC (Through Week 8) n = 165
Value	49.1	54.8	44.6	49.7

LPV/r 800/200 mg QD Tablet vs LPV/r 800/200 mg QD SGC (Through Week 8) vs LPV/r 400/100 mg BID Tablet vs LPV/r 400/100 mg BID SGC (Through Week 8): p >0.100, Cochran-Mantel-Haenszel

Population analysed: All randomized subjects who received at least 1 dose of study drug.

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

Time frame: Week 48. Number. Unit: Percentage of Subjects

Measure	LPV/r 800/200 mg QD Tablet n = 333	LPV/r 800/200 mg QD SGC (Through Week 8) n = 0	LPV/r 400/100 mg BID Tablet n = 331	LPV/r 400/100 mg BID SGC (Through Week 8) n = 0
Value	77.2	–	75.8	–

LPV/r 800/200 mg QD Tablet vs LPV/r 400/100 mg BID Tablet: percentage of subjects responding: 1.3 (95% CI -5.1 to 7.8), p = 0.715, normal approx. to the binomial distr.

Population analysed: Intent-to-treat noncompleters considered failures (ITT, NC=F); all randomized subjects who received at least 1 dose of study drug.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4.9% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LPV/r 800/200 mg QD Tablet	37 of 333 (11.1%)	292 of 333 (87.7%)	Not reported
LPV/r 400/100 mg BID Tablet	50 of 331 (15.1%)	287 of 331 (86.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Human Immunodeficiency Virus Infections

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel E Cohen, MD study director

Abbott

129 sites in 19 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Spain, Canada, France, Germany and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks (time frame: Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00262522.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2012.