HIV InfectionsPhase 2NCT00043953
Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects
A Phase 2 study testing Lopinavir/ritonavir, Saquinavir mesylate and Lamivudine/zidovudine in people with HIV Infections, run by Abbott at 11 sites in 2 countries.
Trial summary
The objectives of this study are to explore the metabolic toxicities associated with lopinavir/ritonavir (LPV/r) plus saquinavir mesylate (INV) versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the overall safety, tolerability and efficacy of LPV/r plus INV versus LPV/r plus Combivir in… 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?
- Lopinavir/ritonavir, Saquinavir mesylate and Lamivudine/zidovudine
- How many people
- 30 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Aug 2002to 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 naïve to antiretroviral treatment (subjects may not have more than 7 days of any antiretroviral treatment).
- Subject is at least 18 years of age, inclusive.
- 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:condoms, sponge, foams, jellies, diaphragm or intrauterine device(IUD), a vasectomized partner, total abstinence from sexual intercourse
- If female, the results of a urine pregnancy test performed at screening (urine specimen obtained no earlier than 28 days prior to study drug administration) is negative.
- Subject is not breast-feeding.
- Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
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- Subject has no 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 participating in this study.
- Subject does not require and agrees not to take any of the following medications for the duration of the study: midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, propafenone, flecainide, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and methylergonovine), rifampin, lovastatin, simvastatin, and St. John's wort.
- Subject agrees not to take any medication during the study, including over-the-counter medicine, alcohol or recreational drugs without the knowledge and permission of the principal investigator.
- Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of screening.
- Subject has a plasma HIV RNA level of greater than 400 copies/mL at screening.
- Subject agrees to take all doses of the study drug from the bottles provided by the sponsor (rather than other containers, i.e., "pill box").
- 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
- Subject has a history of an allergic reaction or significant sensitivity to LPV/r, INV or Combivir.
- Subject has a history of substance abuse or psychiatric illness that could preclude adherence with the protocol.
- Screening laboratory analyses show any of the following abnormal laboratory results:
- Hemoglobin ≤ 10.0 g/dL
- Absolute neutrophil count ≤ 1000 cells/µL
- Platelet count ≤ 50,000 per mL
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- ALT or AST ≥ 3.0 x Upper Limit of Normal (ULN)
- Creatinine ≥ 1.5 x Upper Limit of Normal (ULN)
- Subject has received any investigational drug within 30 days prior to study drug administration.
- For any reason, subject is considered by the investigator to be an unsuitable candidate for the study.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States9 sites
Community Research Initiative of New England
Boston, Massachusetts, 02215
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7215
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Duke University Medical Center
Durham, North Carolina, 27710
AHF Research
Los Angeles, California, 90015
Pacific Horizon Medical Group
San Francisco, California, 94115
Stephen Becker, MD
San Francisco, California, 94115
Community Research Initiative of New England
Springfield, Massachusetts, 01107
Harbor UCLA, Research & Education Institute
Torrance, California, 90502
Canada2 sites
University of Ottawa at the Ottawa Health Research Institute
Ottawa, K1H 8L6
University of Ottawa Health Research Institute
Ottawa, K1H 8L6
About this study
Official title: A Phase II Study of Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects
The objectives of this study are to explore the metabolic toxicities associated with lopinavir/ritonavir (LPV/r) plus saquinavir mesylate (INV) versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the overall safety, tolerability and efficacy of LPV/r plus INV versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the pharmacokinetics of 400 mg INV taken twice a day (BID), 600 mg INV BID and 800 mg INV BID in combination with 400 mg lopinavir/100 mg ritonavir plus 150 mg lamivudine/300 mg zidovudine BID.
- Conditions
- HIV Infections
- Being tested
- Lopinavir/ritonavir, Saquinavir mesylate, Lamivudine/zidovudine
- 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.
Lopinavir/ritonavirDrug
Saquinavir mesylateDrug
Lamivudine/zidovudineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with plasma HIV RNA level below 50 copies/mL
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2002 (estimated)
- Study startAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Barbara A da Silva, M.D., Study director, Associate Medical Director, Antiviral Global Project Team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043953
- Sponsor's protocol ID
- M01-384
- Status last verified
- Sep 2007
- First submitted
- 15 Aug 2002
- Last updated
- 27 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects
- ClinicalTrials.gov ID
- NCT00043953
- Acronym / sponsor ID
- M01-384
- Conditions
- HIV Infections
- Keywords
- treatment naive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- First posted
- 19 Aug 2002 (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 objectives of this study are to explore the metabolic toxicities associated with lopinavir/ritonavir (LPV/r) plus saquinavir mesylate (INV) versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the overall safety, tolerability and efficacy of LPV/r plus INV versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the pharmacokinetics of 400 mg INV taken twice a day (BID), 600 mg INV BID and 800 mg INV BID in combination with 400 mg lopinavir/100 mg ritonavir plus 150 mg lamivudine/300 mg zidovudine BID.
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 (13 listed)
- Subject is naïve to antiretroviral treatment (subjects may not have more than 7 days of any antiretroviral treatment).
- Subject is at least 18 years of age, inclusive.
- 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:condoms, sponge, foams, jellies, diaphragm or intrauterine device(IUD), a vasectomized partner, total abstinence from sexual intercourse
- If female, the results of a urine pregnancy test performed at screening (urine specimen obtained no earlier than 28 days prior to study drug administration) is negative.
- Subject is not breast-feeding.
Key exclusion criteria (10 listed)
- Subject has a history of an allergic reaction or significant sensitivity to LPV/r, INV or Combivir.
- Subject has a history of substance abuse or psychiatric illness that could preclude adherence with the protocol.
- Screening laboratory analyses show any of the following abnormal laboratory results:
- Subject has received any investigational drug within 30 days prior to study drug administration.
- For any reason, subject is considered by the investigator to be an unsuitable candidate for the study.
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 | Drug | – |
| Saquinavir mesylate | Drug | – |
| Lamivudine/zidovudine | Drug | – |
Primary outcome
Proportion of subjects with plasma HIV RNA level below 50 copies/mL
Time frame: 48 weeks
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 27 Sep 2007.
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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 A da Silva, M.D. study director
Associate Medical Director, Antiviral Global Project Team
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lopinavir/ritonavir, Saquinavir mesylate and Lamivudine/zidovudine in people with HIV Infections, run by Abbott at 11 sites in 2 countries.
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 13 inclusion and 10 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 27 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. 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 plasma HIV RNA level below 50 copies/mL (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2007.