HIV InfectionsPhase 2NCT00075231
A Simplified Kaletra® (Lopinavir/Ritonavir)-Based Therapy Versus a Sustiva® (Efavirenz)-Based Standard of Care in Previously Non-Treated HIV-Infected Subjects
A Phase 2 study testing Kaletra® (lopinavir/ritonavir), Combivir® (lamivudine, zidovudine) and Sustiva® (efavirenz) in people with HIV Infections, run by Abbott at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a simplified lopinavir-ritonavir based therapy will continue to keep the viral load to very low levels after initial treatment with a combination of Kaletra® (lopinavir/ritonavir) plus Combivir® (lamivudine/zidovudine). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Kaletra® (lopinavir/ritonavir), Combivir® (lamivudine, zidovudine) and Sustiva® (efavirenz)
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years of age.
- Subject is confirmed HIV positive and in the investigator's opinion requires antiretroviral (ARV) therapy.
- Subject is naïve to HIV ARV therapy or has received < 7 days total of any HIV ARV therapy > 30 days prior to study drug administration.
- Subject's HIV RNA is >= 1000 copies/mL at screening.
- If sexually active, subject agrees to use safe sex practices to reduce risk of HIV transmission (e.g., male or female condom, vaginal dam, etc.).
- If female, the results of a urine pregnancy test performed at screening and on Day 1/Baseline are both negative.
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- If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:
- A. Condoms, sponge, foams, jellies, diaphragm or intrauterine device.
- B. A vasectomized partner.
- C. Total abstinence from sexual intercourse.
- Subject is not breastfeeding.
- Subject's vital signs, physical examination, and laboratory results do not exhibit evidence of acute illness.
- Subject has a Karnofsky score greater than or equal to 70.
- Subject agrees not to take any drugs during the study, including over-the-counter medicines, vitamins, mineral supplements, herbal preparations, alcohol, or recreational drugs without the knowledge and permission of the investigator.
- Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of initiating study drug.
- Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
Who cannot join
- A subject will be excluded from the study if he/she meets any of the following criteria:
- Subject has a history of an allergic reaction or significant sensitivity to lopinavir, ritonavir, lamivudine, zidovudine, efavirenz, or to any inert materials contained in the study drug formulations.
- Subject has significant history of cardiac, renal, neurologic, psychiatric, oncologic, endocrinologic, metabolic, or hepatic disease that would, in the opinion of the investigator, adversely affect his/her participation in this study.
- Subject is currently taking any drug (medicinal or herbal) that is contraindicated and/or not to be co-administered with any of the three study drugs as defined in the current locally approved prescribing information.
- Subject has a history of drug and/or alcohol abuse or psychiatric illness that in the investigator's opinion could preclude compliance with the protocol.
- Subject is receiving immunomodulatory agents, colony stimulating factor, bone marrow stimulants (e.g., erythropoietin [Procrit®, Epogen®] or filgrastim [Neupogen®]), ganciclovir, interferon-alpha, and other bone marrow suppressive or cytotoxic agents.
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- The TRUGENE HIV-1 resistance report indicates resistance or possible resistance to the study reverse transcriptase inhibitor(s) [RTI(s)] (efavirenz, lamivudine or zidovudine) OR the presence of any mutation in the protease gene leading to an amino acid substitution at the following loci: 8, 30, 32, 46, 47, 48, 50, 54, 82, 84, or 90 OR four or more mutations at the following loci: 10, 20, 24, 36, 53, 63, or 71.
- Screening laboratory analyses show any of the following abnormal laboratory results: Presence of Hepatitis B surface antigen (HBsAg); Hemoglobin <= 9.5 g/dL; Absolute neutrophil count <= 1000 cells/mL; Platelet count <= 50,000 per mL; ALT (SGPT) or AST (SGOT) >= 3.0 x Upper Limit of Normal (ULN); Fasting Triglycerides > 750 mg/dL; Fasting Cholesterol > 300 mg/dL; Creatinine >= 1.5 x Upper Limit of Normal (ULN); Fasting serum glucose > 126 mg/dL
- Subject is taking a prescribed lipid lowering medication such as HMG-CoA Reductase Inhibitors (statin) or fibrate medications.
- Subject has a history of diabetes mellitus.
- Subject has received any investigational drug or vaccine within 30 days prior to study drug administration.
- For any reason, subject is considered by the investigator to be an unsuitable candidate to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fountain Valley Regional Hospital and Medical Center
Fountain Valley, California, 92708
About this study
Official title: A Randomized, Open-Label Study Exploring a Simplified Kaletra® (Lopinavir/Ritonavir)-Based Therapy Versus a Sustiva® (Efavirenz)-Based Standard of Care in Previously Non-Treated HIV-Infected Subjects
The purpose of this study is to determine whether a simplified lopinavir-ritonavir based therapy will continue to keep the viral load to very low levels after initial treatment with a combination of Kaletra® (lopinavir/ritonavir) plus Combivir® (lamivudine/zidovudine).
- Conditions
- HIV Infections
- Being tested
- Kaletra® (lopinavir/ritonavir), Combivir® (lamivudine, zidovudine), Sustiva® (efavirenz)
- Keywords
- Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaletra® (lopinavir/ritonavir)Drug
Combivir® (lamivudine, zidovudine)Drug
Sustiva® (efavirenz)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with a plasma HIV RNA level below 50 copies/mL at Week 96.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2004 (estimated)
- Study startDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Barbara da Silva, M.D., Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075231
- Sponsor's protocol ID
- M03-613
- Status last verified
- Sep 2006
- First submitted
- 6 Jan 2004
- Last updated
- 2 Oct 2006
- Results posted
- No
Publications
Brown TT, McComsey GA, King MS, Qaqish RB, Bernstein BM, da Silva BA. Loss of bone mineral density after antiretroviral therapy initiation, independent of antiretroviral regimen. J Acquir Immune Defic Syndr. 2009 Aug 15;51(5):554-61. doi: 10.1097/QAI.0b013e3181adce44.
PubMed 19512937Cameron DW, da Silva BA, Arribas JR, Myers RA, Bellos NC, Gilmore N, King MS, Bernstein BM, Brun SC, Hanna GJ. A 96-week comparison of lopinavir-ritonavir combination therapy followed by lopinavir-ritonavir monotherapy versus efavirenz combination therapy. J Infect Dis. 2008 Jul 15;198(2):234-40. doi: 10.1086/589622.
PubMed 18540803
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study Exploring a Simplified Kaletra® (Lopinavir/Ritonavir)-Based Therapy Versus a Sustiva® (Efavirenz)-Based Standard of Care in Previously Non-Treated HIV-Infected Subjects
- ClinicalTrials.gov ID
- NCT00075231
- Acronym / sponsor ID
- M03-613
- Conditions
- HIV Infections
- Keywords
- Treatment Naive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- First posted
- 8 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a simplified lopinavir-ritonavir based therapy will continue to keep the viral load to very low levels after initial treatment with a combination of Kaletra® (lopinavir/ritonavir) plus Combivir® (lamivudine/zidovudine).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subject is at least 18 years of age.
- Subject is confirmed HIV positive and in the investigator's opinion requires antiretroviral (ARV) therapy.
- Subject is naïve to HIV ARV therapy or has received < 7 days total of any HIV ARV therapy > 30 days prior to study drug administration.
- Subject's HIV RNA is >= 1000 copies/mL at screening.
- If sexually active, subject agrees to use safe sex practices to reduce risk of HIV transmission (e.g., male or female condom, vaginal dam, etc.).
Key exclusion criteria (12 listed)
- A subject will be excluded from the study if he/she meets any of the following criteria:
- Subject has a history of an allergic reaction or significant sensitivity to lopinavir, ritonavir, lamivudine, zidovudine, efavirenz, or to any inert materials contained in the study drug formulations.
- Subject has significant history of cardiac, renal, neurologic, psychiatric, oncologic, endocrinologic, metabolic, or hepatic disease that would, in the opinion of the investigator, adversely affect his/her participation in this study.
- Subject is currently taking any drug (medicinal or herbal) that is contraindicated and/or not to be co-administered with any of the three study drugs as defined in the current locally approved prescribing information.
- Subject has a history of drug and/or alcohol abuse or psychiatric illness that in the investigator's opinion could preclude compliance with the protocol.
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 |
|---|---|---|
| Kaletra® (lopinavir/ritonavir) | Drug | – |
| Combivir® (lamivudine, zidovudine) | Drug | – |
| Sustiva® (efavirenz) | Drug | – |
Primary outcome
Proportion of subjects with a plasma HIV RNA level below 50 copies/mL at Week 96.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2006.
- Derived from this study: PubMed 19512937Brown TT, McComsey GA, King MS, Qaqish RB, Bernstein BM, da Silva BA. Loss of bone mineral density after antiretroviral therapy initiation, independent of antiretroviral regimen. J Acquir Immune Defic Syndr. 2009 Aug 15;51(5):554-61. doi: 10.1097/QAI.0b013e3181adce44.
- Derived from this study: PubMed 18540803Cameron DW, da Silva BA, Arribas JR, Myers RA, Bellos NC, Gilmore N, King MS, Bernstein BM, Brun SC, Hanna GJ. A 96-week comparison of lopinavir-ritonavir combination therapy followed by lopinavir-ritonavir monotherapy versus efavirenz combination therapy. J Infect Dis. 2008 Jul 15;198(2):234-40. doi: 10.1086/589622.
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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.
Barbara da Silva, M.D. study director
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kaletra® (lopinavir/ritonavir), Combivir® (lamivudine, zidovudine) and Sustiva® (efavirenz) in people with HIV Infections, run by Abbott at 1 site in United States.
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 16 inclusion and 12 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 2 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of subjects with a plasma HIV RNA level below 50 copies/mL at Week 96.. 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 NCT00075231, which also lists 2 linked publications.
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 2 Oct 2006.