Safety and Effectiveness of Lopinavir/Ritonavir in Individuals Who Have Failed Prior HIV Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00357552
Recruitment Status : Completed
First Posted : July 27, 2006
Results First Posted : September 25, 2012
Last Update Posted : March 20, 2018
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Emtricitabine/Tenofovir disoproxil fumarate
Drug: Lopinavir/Ritonavir

  Participant Flow

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
LPV/r Monotherapy Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.

Baseline Measures
   LPV/r Monotherapy 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      123 100.0% 
>=65 years      0   0.0% 
[Units: Years]
Mean (Standard Deviation)
 39.4  (8.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      70  56.9% 
Male      53  43.1% 
Region of Enrollment 
[Units: Participants]
South Africa   22 
Thailand   24 
India   12 
Malawi   40 
Tanzania   25 

  Outcome Measures

1.  Primary:   Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy   [ Time Frame: From study entry to week 24 ]

2.  Primary:   Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.   [ Time Frame: From study entry to week 24 ]

3.  Secondary:   Number of Screened Subjects With at Least One NNRTI, or NRTI-associated Resistance Mutation at A5230 Screening.   [ Time Frame: Screening ]

4.  Secondary:   Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.   [ Time Frame: Study entry to Week 104 ]

5.  Secondary:   Number of Participants With Study-targeted Diagnoses and Clinical Events   [ Time Frame: Study entry to week 104 ]

6.  Secondary:   Number of Subjects With at Least One New PI-associated Resistance Mutation at Time of Virologic Failure.   [ Time Frame: At time of virologic failure ]

7.  Secondary:   Percentage of Subjects Reporting Not Skipping Medications in the Last Month.   [ Time Frame: Study entry and weeks 2, 4, 8, 12, 16, 20, and 24 ]

8.  Secondary:   Time to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification   [ Time Frame: From LPV/r intensification to week 104 ]

9.  Secondary:   Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma   [ Time Frame: At study entry and weeks 24 and 48 ]

10.  Secondary:   HIV-1 Viral Sequence as Ascertained From Paired DBS and Plasma   [ Time Frame: At study entry and virologic failure ]

11.  Secondary:   Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104   [ Time Frame: At Weeks 0, 12, 16, 20, 24, 32, 40, 48, 56, 68, 80, 92, 104 ]

12.  Secondary:   Change in CD4+ Cell Counts From Study Entry to Week 104   [ Time Frame: Study entry and week 104 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information