NCT00357552

A Pilot Study of Lopinavir/Ritonavir in Participants Experiencing Virologic Relapse on NNRTI-Containing Regimens

Completed NA Results posted Last updated 21 February 2018

What this trial tests

NA trial testing Emtricitabine/Tenofovir disoproxil fumarate in HIV Infections in 123 participants. Completed in 1 May 2012.

Timeline

1 January 2008

Primary endpoint
1 October 2010

1 May 2012

Quick facts

Lead sponsor	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	123
Start date	1 January 2008
Primary completion	1 October 2010
Estimated completion	1 May 2012
Sites	5 locations across India, Malawi, South Africa, Tanzania, Thailand

Drugs / interventions tested

• Emtricitabine/Tenofovir disoproxil fumarate — full drug profile →
• Lopinavir/Ritonavir

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Who can join

18 and older, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy
  Time frame: From study entry to week 24
  Virologic success at week 24 on LPV/r monotherapy was defined as remaining on LPV/r monotherapy at week 24 without prior virologic failure. Virologic failure was met with either of these two conditions: (i) failure to suppress HIV-1 RNA to \< 400 copies/mL by week 24 or (ii) confirmed HIV-1 RNA \>= 400 copies/mL after confirmed HIV-1 RNA \< 400 copies/mL.
• 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
  Probability of Grade 3 or 4 sign or symptom, or laboratory toxicity over 24 weeks on study using Kaplan-Meier estimates of the cumulative probability of Grade 3 or 4 sign or symptom, or laboratory toxicity at week 24. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Versi

Sponsor's own description

Most anti-HIV regimens include a non-nucleoside reverse transcriptase inhibitor (NNRTI); however, some individuals fail on these regimens. The purpose of this study is to evaluate the safety and effectiveness of the protease inhibitor (PI) lopinavir/ritonavir (LPV/r) in HIV infected individuals who are failing an anti-HIV regimen that includes an NNRTI.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lopinavir/ritonavir monotherapy after virologic failure of first-line antiretroviral therapy in resource-limited settings.
   Bartlett JA, Ribaudo HJ, Wallis CL, Aga E, et al · · 2012 · cited 38× · PMID 22441252 · DOI 10.1097/qad.0b013e328353b066
2. Lopinavir/Ritonavir Monotherapy as Second-line Antiretroviral Treatment in Resource-Limited Settings: Week 104 Analysis of AIDS Clinical Trials Group (ACTG) A5230.
   Kumarasamy N, Aga E, Ribaudo HJ, Wallis CL, et al · · 2015 · cited 16× · PMID 25694653 · DOI 10.1093/cid/civ109
3. Nucleic acid amplification testing using dried blood spots to confirm the diagnosis of HIV-1 in adults.
   Pinsky BA, Sahoo MK, Manasa J, Makadzange T, et al · · 2024 · PMID 39566166 · DOI 10.1016/j.jcv.2024.105746