HIV InfectionsPhase 2NCT00038220
Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients
A Phase 2 study testing Lopinavir/ritonavir, Efavirenz and Lamivudine in people with HIV Infections, run by Abbott at 1 site in United States.
Trial summary
The purpose of this study is to see if a novel 4-drug anti-HIV combination can suppress the growth of HIV in patients infected with the virus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Lopinavir/ritonavir, Efavirenz and Lamivudine
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2000to 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have HIV Infection.
- Age 18 to 65 years old.
- Show no signs of recent illness other than HIV infection.
- Agree to use a barrier method of birth control during the study and for 30 days after study.
Who cannot join
- Are unable to follow study requirements (in the opinion of the investigator).
- Are pregnant or breast-feeding.
- Are unable to take medications by mouth.
- Have chronic nausea or vomiting.
- Have cancer other than Kaposi's sarcoma or basal cell carcinoma.
- Have active, serious infections (other than HIV) requiring antibiotic injections within 15 days prior to screening.
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- Are taking any medications that are not allowed with ABT-378/r and efavirenz.
- Are taking or have taken any other experimental drugs, antiretroviral drugs, or drugs that affect the immune system within 30 days of start of study without consent of the medical monitor.
- Are receiving or have received radiation therapy within 30 days of start of study without consent of the medical monitor.
- Have a history of drug abuse or mental illness that would prevent the patient from following the protocol requirements.
- Have a history of kidney or bone disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Aaron Diamond AIDS Research Center - Rockefeller University
New York, New York, 10021
About this study
Official title: A Phase I/II, Open Label Study to Evaluate the Ability of Combination Therapy With ABT-378/Ritonavir (Kaletra), Lamivudine (Epivir), Efavirenz (Sustiva)and Tenofovir DF to Completely Suppress Viral Replication in Subjects Infected With HIV-1
The purpose of this study is to see if a novel 4-drug anti-HIV combination can suppress the growth of HIV in patients infected with the virus.
- Conditions
- HIV Infections
- Being tested
- Lopinavir/ritonavir, Efavirenz, Lamivudine, Tenofovir DF
- Keywords
- HIV
- 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
EfavirenzDrug
LamivudineDrug
Tenofovir DFDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects in each group demonstrating complete suppression of viral replication at Week 144.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2002 (estimated)
- Study startJul 2000
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
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scott Brun, M.D., Study director, Head, Antiviral Global Project Team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038220
- Sponsor's protocol ID
- M00-154
- Status last verified
- Jul 2006
- First submitted
- 29 May 2002
- Last updated
- 27 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open Label Study to Evaluate the Ability of Combination Therapy With ABT-378/Ritonavir (Kaletra), Lamivudine (Epivir), Efavirenz (Sustiva)and Tenofovir DF to Completely Suppress Viral Replication in Subjects Infected With HIV-1
- ClinicalTrials.gov ID
- NCT00038220
- Acronym / sponsor ID
- M00-154
- Conditions
- HIV Infections
- Keywords
- HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jul 2000
- First posted
- 30 May 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 purpose of this study is to see if a novel 4-drug anti-HIV combination can suppress the growth of HIV in patients infected with the virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have HIV Infection.
- Age 18 to 65 years old.
- Show no signs of recent illness other than HIV infection.
- Agree to use a barrier method of birth control during the study and for 30 days after study.
Key exclusion criteria (11 listed)
- Are unable to follow study requirements (in the opinion of the investigator).
- Are pregnant or breast-feeding.
- Are unable to take medications by mouth.
- Have chronic nausea or vomiting.
- Have cancer other than Kaposi's sarcoma or basal cell carcinoma.
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 | – |
| Efavirenz | Drug | – |
| Lamivudine | Drug | – |
| Tenofovir DF | Drug | – |
Primary outcome
Proportion of subjects in each group demonstrating complete suppression of viral replication at Week 144.
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 Jul 2006.
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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.
Scott Brun, M.D. study director
Head, Antiviral Global Project Team
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 Lopinavir/ritonavir, Efavirenz and Lamivudine 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 4 inclusion and 11 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 Jul 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 in each group demonstrating complete suppression of viral replication at Week 144.. 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 Jul 2006.