HIV InfectionsPhase 1/2NCT00004578
ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects
A Phase 1/2 study testing Lopinavir/Ritonavir, Lamivudine and Stavudine in people with HIV Infections, run by Abbott at 10 sites in United States.
Trial summary
To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects. 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, Lamivudine and Stavudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesUnited States
- Study dates
- Nov 1997to Apr 2005
- Phase
- Phase 1/2
- 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
- HIV-1 positive
- antiretroviral-adult males
- non-pregnant
- non-lactating females at least 18-years old with plasma HIV-1 RNA > 5000 copies/mL, who were not acutely ill
Who cannot join
- History of:
- prior antiretroviral therapy
- significant drug hypersensitivity
- psychiatric illness that precludes compliance
- an active substance abuser
- positive test results for drug abuse
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- abnormal lab test results (hemoglobin, absolute neutrophil count, platelet count, SGPT/AST or SGPT/ALT, creatinine, fasting triglycerides, significant abnormal ECG results
- pregnancy or lactating female
- received another investigational drug within 28 days of study initiation
- unlikely to comply or unsuitable candidate in the opinion of the investigator
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Pacific Oaks Research
Beverly Hills, California, 90211
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27516
Northwestern University Medical School
Chicago, Illinois, 60611
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
Cornell Clinical Trials Unit - Chelsea Center
New York, New York, 10011
About this study
Official title: Phase I/II Study of ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected Patients
To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.
- Conditions
- HIV Infections
- Being tested
- Lopinavir/Ritonavir, Lamivudine, Stavudine
- Keywords
- Stavudine, HIV Protease Inhibitors, Ritonavir, Lamivudine, Reverse Transcriptase Inhibitors
- 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
Also called ABT-387, Kaletra
Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs
LamivudineDrug
150 mg, every 12 hours
StavudineDrug
40 mg every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Group 1, n=32 initiated with ABT-378 \& ritonavir; after 3 wks stavudine and lamivudine was added. Receives: Drug: Lopinavir/Ritonavir; Drug: Lamivudine; Drug: Stavudine |
| 2 | Active comparator | Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed. Receives: Drug: Lopinavir/Ritonavir; Drug: Lamivudine; Drug: Stavudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with viral load below the limit of quantitation
Measured: 24 weeks
Time to loss of virologic response
Measured: 48 weeks
Secondary outcomes (1)
Proportion of subjects with viral load below the limit of quantitation at each visit
Measured: At each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startNov 1997
- Primary completionApr 2005
- Study completionApr 2005
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- George Hanna, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004578
- Sponsor's protocol ID
- 285A
- Other IDs
- M97-720
- Status last verified
- Apr 2008
- First submitted
- 2 Nov 1999
- Last updated
- 3 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Murphy R, King M, Brun S, Orth K, Hicks C, Eron J, Thommes J, Gulick R, Thompson M, White C, Benson C, Hammer S, Kessler H, Bertz R, Hsu A, Kempf D, Sun E, Japour A. ABT-378/ritonavir therapy in antiretroviral-naive HIV-I infected patients for 24 weeks. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:69 (abstract no 15)
Murphy RL, Brun S, Hicks C, Eron JJ, Gulick R, King M, White AC Jr, Benson C, Thompson M, Kessler HA, Hammer S, Bertz R, Hsu A, Japour A, Sun E. ABT-378/ritonavir plus stavudine and lamivudine for the treatment of antiretroviral-naive adults with HIV-1 infection: 48-week results. AIDS. 2001 Jan 5;15(1):F1-9. doi: 10.1097/00002030-200101050-00002.
PubMed 11192874
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00004578
- Acronym / sponsor ID
- 285A
- Conditions
- HIV Infections
- Keywords
- Stavudine, HIV Protease Inhibitors, Ritonavir, Lamivudine, Reverse Transcriptase Inhibitors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Nov 1997
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 31 Aug 2001 (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.
To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Lopinavir/Ritonavir, Drug: Lamivudine, Drug: StavudineGroup 1, n=32 initiated with ABT-378 \& ritonavir; after 3 wks stavudine and lamivudine was added. |
| 2 | Active comparator | Drug: Lopinavir/Ritonavir, Drug: Lamivudine, Drug: StavudineGroup II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV-1 positive
- antiretroviral-adult males
- non-pregnant
- non-lactating females at least 18-years old with plasma HIV-1 RNA > 5000 copies/mL, who were not acutely ill
Key exclusion criteria (10 listed)
- History of:
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/RitonavirAlso: ABT-387, KaletraLopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs | Drug | 1, 2 |
| Lamivudine150 mg, every 12 hours | Drug | 1, 2 |
| Stavudine40 mg every 12 hours | Drug | 1, 2 |
Primary outcome
Proportion of subjects with viral load below the limit of quantitation
Time frame: 24 weeks
Time to loss of virologic response
Time frame: 48 weeks
1 secondary outcome
Proportion of subjects with viral load below the limit of quantitation at each visit
Time frame: At each visit
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 3 Apr 2008.
- BackgroundMurphy R, King M, Brun S, Orth K, Hicks C, Eron J, Thommes J, Gulick R, Thompson M, White C, Benson C, Hammer S, Kessler H, Bertz R, Hsu A, Kempf D, Sun E, Japour A. ABT-378/ritonavir therapy in antiretroviral-naive HIV-I infected patients for 24 weeks. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:69 (abstract no 15)
- Background: PubMed 11192874Murphy RL, Brun S, Hicks C, Eron JJ, Gulick R, King M, White AC Jr, Benson C, Thompson M, Kessler HA, Hammer S, Bertz R, Hsu A, Japour A, Sun E. ABT-378/ritonavir plus stavudine and lamivudine for the treatment of antiretroviral-naive adults with HIV-1 infection: 48-week results. AIDS. 2001 Jan 5;15(1):F1-9. doi: 10.1097/00002030-200101050-00002.
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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.
George Hanna, MD study director
Abbott
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lopinavir/Ritonavir, Lamivudine and Stavudine in people with HIV Infections, run by Abbott at 10 sites 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 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 3 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 viral load below the limit of quantitation (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 NCT00004578, 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 3 Apr 2008.