Induction-maintenance of Lopinavir/r in HIV-infected Subjects

This study will assess the safety, tolerability and antiviral activity of a simplified PI-based treatment regimen (Kaletra,ä) compared to conventional HAART regimens in patients infected with HIV-1 who are on their first boosted-PI antiretroviral treatment regimen.

The potency of the antiviral activity of Kaletra has been clearly demonstrated in a wide spectrum of patients in a number of different clinical trials.6-9 The durable viral suppression seen after 4 years of therapy10 proves that it can provide effective, long-term treatment for people with HIV-1.

Data from one of these trials (M97-720),6 an ongoing Phase II study of lopinavir/ritonavir in combination with NRTIs suggests there may be a role for monoclass therapy with Kaletra in the treatment of HIV-1-infection.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fundacion Huesped, Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject has confirmed his or her willingness to participate in this study after being informed of all aspects of the trial that are relevant to his or her decision to take part, by signing and dating the IRB / IEC approved informed consent form.
Subject is HIV positive and on their first antiretroviral treatment regimen, based on any two NRTIs plus lopinavir/ritonavir or a ritonavir-boosted PI combination. Subject must have had no previous exposure to other regimens.
Subject has a viral load <50 copies/ml at the time of baseline evaluation for at least 6 months.
Subject has a CD4 cell count ³ 100 cells/mm3.
Subject is aged >18 years.
Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
Subject has not been treated for an active opportunistic infection within 30 days of screening.
If female, subject has a negative pregnancy test and agrees to use, for the duration of the study, a barrier method of birth control that has a history of proven reliability as judged by the investigator.
Subject does not require and agrees not to take, for the duration of the study, any medication that is contraindicated with any of the antiretroviral drugs in their treatment regimen. The subject agrees not to take any medication, including over-the-counter medicine, alcohol, or recreational drugs without the knowledge and permission of the principal investigator

Exclusion criteria

Subject has current uncontrolled substance abuse or psychiatric illness that could preclude compliance with the protocol.
Subject has a viral load of > 50 copies/ml
Subject is HBsAg +
Subject has active tuberculosis or an opportunistic infection.
Subject has active malignancy (except Kaposi's Sarcoma).
Subject has liver failure as evidenced by ALT / AST > 5 x Upper Limit of Normal (ULN).
Female subject is pregnant or lactating.
Subject has received an investigational drug within 30 days prior to the initiation of the study.
Subject has modified his/her antiretroviral therapy during the 3 months prior to baseline or is intending to do so during the course of the study.

Treatment and study plan

Lopinavir/ritonavir simplification strategy

Drug

Simplification

Other names: Kaletra monotherapy simplification strategy

Primary outcomes

Proportion of patients remaining undetectable below 50 copies/mL at 48 weeks

Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Fundación Huésped

Other

Collaborators

Abbott

Registry information

Official study title

Study ACA-ARGE-04-001 "A Pilot, Open-Label Study Assessing Safety, Tolerability, Efficacy of a Simplified Lopinavir/Ritonavir Induction/Maintenance Therapy in HIV-Infected Subjects on Their First Protease Inhibitor-Based Regimen".

Important dates

Study start: 2005
Primary completion: 2009
Study completion: 2009
First posted: Sep 12, 2005
Registry last updated: Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed