HIV InfectionsNCT00006591
Ritonavir and Agenerase Treatment for Patients Who Have Failed Previous Anti-HIV Treatment
A study testing Ritonavir and Amprenavir in people with HIV Infections, run by Gathe, Joseph, M.D. at 1 site in United States.
Trial summary
The purpose of this study is to determine if treatment with an anti-HIV drug containing ritonavir and Agenerase is safe and can lower the level of HIV in the blood in patients who have failed an anti-HIV drug treatment containing nelfinavir. 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?
- Ritonavir and Amprenavir
- How many people
- Not given
- Where
- 1 siteUnited 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are 18 years of age or older.
- Are HIV-positive.
- Have a viral load (level of HIV in the body) of more than 1,000 copies/ml.
- Have had more than 12 weeks of prior anti-HIV drug treatment.
- Have failed a previous anti-HIV treatment containing nelfinavir as the only protease inhibitor.
- Are responsive to Agenerase.
- Are able to follow study requirements.
Who cannot join
- Patients will not be eligible for this study if they:
- Are intolerant to ritonavir (an anti-HIV drug).
- Have or have had problems with absorption.
- Have liver disease or damage.
- Have pancreatic disease or damage.
- Have taken any protease inhibitor other than nelfinavir.
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- Are receiving investigational drugs or devices from another study.
- Are pregnant or breast-feeding.
- Currently use triazolam, astemizole, ergot medications, cisapride, midazolam, bepridil, rifampin, terfenadine, or pimozide.
- Have a bleeding disorder.
- Have previously been treated with Agenerase.
- Are receiving nonnucleosides.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Efficacy of a Ritonavir-Enhanced Agenerase Regimen as Salvage Therapy in HIV-Infected Individuals
The purpose of this study is to determine if treatment with an anti-HIV drug containing ritonavir and Agenerase is safe and can lower the level of HIV in the blood in patients who have failed an anti-HIV drug treatment containing nelfinavir.
Read the detailed description
HIV-infected patients will be treated with a ritonavir-enhanced Agenerase regimen.
- Conditions
- HIV Infections
- Being tested
- Ritonavir, Amprenavir
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, VX 478, Salvage Therapy, Anti-HIV Agents, Drug Monitoring, Nelfinavir, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitonavirDrug
AmprenavirDrug
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
- Gathe, Joseph, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006591
- Sponsor's protocol ID
- 313A
- Other IDs
- APV-430
- Status last verified
- Dec 2004
- First submitted
- 1 Dec 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of a Ritonavir-Enhanced Agenerase Regimen as Salvage Therapy in HIV-Infected Individuals
- ClinicalTrials.gov ID
- NCT00006591
- Acronym / sponsor ID
- 313A
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, VX 478, Salvage Therapy, Anti-HIV Agents, Drug Monitoring, Nelfinavir
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Gathe, Joseph, M.D.
- 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 if treatment with an anti-HIV drug containing ritonavir and Agenerase is safe and can lower the level of HIV in the blood in patients who have failed an anti-HIV drug treatment containing nelfinavir.
Detailed description
HIV-infected patients will be treated with a ritonavir-enhanced Agenerase regimen.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are 18 years of age or older.
- Are HIV-positive.
- Have a viral load (level of HIV in the body) of more than 1,000 copies/ml.
- Have had more than 12 weeks of prior anti-HIV drug treatment.
- Have failed a previous anti-HIV treatment containing nelfinavir as the only protease inhibitor.
Key exclusion criteria (12 listed)
- Are intolerant to ritonavir (an anti-HIV drug).
- Have or have had problems with absorption.
- Have liver disease or damage.
- Have pancreatic disease or damage.
- Have taken any protease inhibitor other than nelfinavir.
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 |
|---|---|---|
| Ritonavir | Drug | – |
| Amprenavir | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ritonavir and Amprenavir in people with HIV Infections, run by Gathe, Joseph, M.D. 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 8 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. 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.
Are results available for this study?
Results are not available in the source record.
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 24 Jun 2005.