HIV InfectionsNCT00002223
A Study of Ritonavir/Indinavir Combination in HIV-Infected Patients
A study testing Indinavir sulfate and Ritonavir in people with HIV Infections, run by Abbott at 6 sites in United States.
Trial summary
The purpose of this study is to determine how many HIV-infected patients continue taking ritonavir/indinavir combination after having taken indinavir three times a day as part of their anti-HIV drug therapy. This study also examines the safety and effectiveness of the ritonavir/indinavir combination. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Indinavir sulfate and Ritonavir
- How many people
- Not given
- Where
- 6 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- HIV infection.
- CD4 cell count greater than 100 cells/microliter.
- HIV RNA levels greater than 400 copies/microliter using the Roche Ultrasensitive assay.
- No acute illness.
- Consent of parent or guardian if less than legal age.
- No prior enrollment in this study.
- All entry criteria for this study met within 15 days prior to enrollment.
Who cannot join
- Co-existing Condition:
- Patients with any of the following symptoms or conditions are excluded:
- Any condition that in the opinion of the investigator may obscure proper observation of the safety or activity of the treatment regimens used in this study.
- Concurrent Medication:
- Excluded:
- Concurrent non-nucleoside reverse transcriptase inhibitors as part of the antiretroviral regimen.
Show all 26Show fewer
- Any of the following medications with ritonavir:
- midazolam, clorazepate, diazepam, estazolam, flurazepam, triazolam, zolpidem, quinidine, amiodarone, encainide, flecainide, propafenone, bepridil, terfenadine, astemizole, cisapride, bupropion, clozapine, rifabutin, meperidine, propoxyphene, piroxicam, pimozide, dihydroergotamine, and ergotamine.
- Any of the following medications with indinavir:
- terfenadine, astemizole, cisapride, triazolam, midazolam. No requirement for rifampin or ketoconazole.
- Any concurrent treatment with other protease inhibitors.
- Other concurrent medication (including over-the-counter medicine or alcohol) without the knowledge and permission of the primary investigator.
- Patients with the following prior conditions are excluded:
- History of significant drug hypersensitivity.
- Psychiatric illness that precludes compliance with the protocol.
- Receipt of investigational drug within 30 days prior to administration of study drug.
- History of acute or chronic pancreatitis.
- Anticipation of poor patient compliance with protocol.
- Prior Medication:
- Excluded:
- Prior treatment with ritonavir.
- Risk Behavior:
- Excluded:
- History of active substance abuse (i.e., recreational drugs or alcohol).
- Included:
- Indinavir 800 mg three times a day plus unspecified nucleosides for at least 3 months.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Urgent Care Ctr / North Broward Hosp District
Fort Lauderdale, Florida, 33316
AIDS Healthcare Foundation
Los Angeles, California, 90027
Tower Infectious Diseases
Los Angeles, California, 90048
Goodgame Med Ctr / Central Florida Research Initiati
Maitland, Florida, 32751
Mount Sinai Med Ctr
New York, New York, 10029
Stephen Hauptman
Philadelphia, Pennsylvania, 19107
About this study
Official title: Ritonavir (ABT-538)/Indinavir Combination Treatment in HIV-Infected Patients Previously Receiving Indinavir 800 mg TID
The purpose of this study is to determine how many HIV-infected patients continue taking ritonavir/indinavir combination after having taken indinavir three times a day as part of their anti-HIV drug therapy. This study also examines the safety and effectiveness of the ritonavir/indinavir combination.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Ritonavir
- Keywords
- Drug Therapy, Combination, Adolescent Behavior, HIV Protease Inhibitors, Ritonavir, Indinavir
- Medical subject headings
- HIV Infections, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indinavir sulfateDrug
RitonavirDrug
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)
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 N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002223
- Sponsor's protocol ID
- 245E
- Other IDs
- M98-823
- Status last verified
- Feb 2009
- First submitted
- 2 Nov 1999
- Last updated
- 20 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ritonavir (ABT-538)/Indinavir Combination Treatment in HIV-Infected Patients Previously Receiving Indinavir 800 mg TID
- ClinicalTrials.gov ID
- NCT00002223
- Acronym / sponsor ID
- 245E
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Adolescent Behavior, HIV Protease Inhibitors, Ritonavir, Indinavir
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- 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.
The purpose of this study is to determine how many HIV-infected patients continue taking ritonavir/indinavir combination after having taken indinavir three times a day as part of their anti-HIV drug therapy. This study also examines the safety and effectiveness of the ritonavir/indinavir combination.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- HIV infection.
- CD4 cell count greater than 100 cells/microliter.
- HIV RNA levels greater than 400 copies/microliter using the Roche Ultrasensitive assay.
- No acute illness.
- Consent of parent or guardian if less than legal age.
Key exclusion criteria (26 listed)
- Any condition that in the opinion of the investigator may obscure proper observation of the safety or activity of the treatment regimens used in this study.
- Concurrent non-nucleoside reverse transcriptase inhibitors as part of the antiretroviral regimen.
- Any of the following medications with ritonavir:
- midazolam, clorazepate, diazepam, estazolam, flurazepam, triazolam, zolpidem, quinidine, amiodarone, encainide, flecainide, propafenone, bepridil, terfenadine, astemizole, cisapride, bupropion, clozapine, rifabutin, meperidine, propoxyphene, piroxicam, pimozide, dihydroergotamine, and ergotamine.
- Any of the following medications with indinavir:
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 |
|---|---|---|
| Indinavir sulfate | Drug | – |
| Ritonavir | Drug | – |
Primary outcome
Not reported in the source record.
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 20 Feb 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indinavir sulfate and Ritonavir in people with HIV Infections, run by Abbott at 6 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 8 inclusion and 26 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 20 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
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.
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 20 Feb 2009.