HIV InfectionsPhase 2NCT00007449
Safety and Effectiveness of the Drug DPC 083 in Combination With Nucleoside Analogue Reverse Transcriptase Inhibitors in HIV-1-Infected Patients Who Are Failing Treatment With Nonnucleoside Reverse Transcriptase Inhibitors
A Phase 2 study testing DPC 083 in people with HIV Infections, run by Dupont Applied Biosciences at 5 sites in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of the study drug DPC 083 combined with 2 nucleoside reverse transcriptase inhibitors (NRTIs) in HIV-infected patients who are failing their nonnucleoside reverse transcriptase inhibitor (NNRTI) treatment. 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?
- DPC 083
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- Start not givento 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
- Patients may be eligible for this study if they:
- Have HIV infection.
- Are at least 18 years old.
- Weigh at least 50 kg.
- Have documented evidence of virologic failure.
- Have screening HIV genotype done while receiving NNRTI treatment, or within 2 weeks after stopping the treatment.
- Have a viral load (amount of HIV in the blood) of at least 1,000 copies/ml within 45 days prior to Day 1 of study.
- Are willing to use an effective barrier method of birth control during the study. Birth control agents taken by mouth or placed under the skin should not be used as the only method of birth control. If the patient stops taking the study drug, he or she should continue to use birth control for the following 3 months.
Who cannot join
- Patients will not be eligible for this study if they:
- Had virologic failure of any treatment containing an HIV protease inhibitor drug.
- Had virologic failure of more than 1 treatment containing an NNRTI drug.
- Have participated in any study using DPC 083.
- Were treated with any experimental NNRTI.
- Have cancer that requires systemic therapy.
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- Have a history of blood clotting problems.
- Have attempted suicide or are in danger of hurting themselves.
- Used illegal injection drugs within 6 months of study entry.
- Do not expect to complete 12 months on the study.
- Have not met requirements for HIV genotyping results.
- Have any disease other than HIV infection or other medical problems that the researchers think may interfere with the study.
- Have difficulty swallowing capsules/tablets.
- Have had treatment with immunomodulatory agents such as interferons, interleukins, or thalidomide within 30 days prior to study entry.
- Are using or have used systemic drugs, including glucocorticoids, that suppress the immune system, for over 2 weeks. (Low levels of prednisone are allowed.)
- Have used carbamazepine, phenytoin, or Hypericum perforatum (St. John's wort) within 30 days of beginning study treatment.
- Have had any vaccination within 3 weeks before study screening.
- Have received any experimental therapy within 30 days of beginning study treatment.
- Are pregnant or breast-feeding.
- Abuse alcohol or drugs.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Bach and Godofsky
Bradenton, Florida, 34205
Northstar Med Clinic
Chicago, Illinois, 60657
AIDS Healthcare Foundation
Los Angeles, California, 90027
Orange Coast Med Group
Newport Beach, California, 92663
Saint Josephs Comprehensive Research Institute
Tampa, Florida, 33607
About this study
Official title: A Phase II, Open Label, Multicenter Study to Assess the Safety and Efficacy of 100 Mg DPC 083 Once Daily in Combination With Nucleoside Analogue Reverse Transcriptase Inhibitors in HIV-1-Infected Subjects Who Are Failing Treatment With a Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Regimen
The purpose of this study is to determine the safety and tolerability of the study drug DPC 083 combined with 2 nucleoside reverse transcriptase inhibitors (NRTIs) in HIV-infected patients who are failing their nonnucleoside reverse transcriptase inhibitor (NNRTI) treatment.
In some studies DPC 083 (an NNRTI) has been found to lower the amount of HIV in the blood (viral load), where drug-resistant types of HIV were not lowered by other NNRTIs. This study will attempt to determine how safe DPC 083 is when it is taken in combination with 2 NRTIs.
Read the detailed description
Preclinical and human pharmacokinetic data suggest that DPC 083 can be administered once daily and provide trough plasma concentrations of free drug that will suppress replication of HIV-1, including strains containing key resistance mutations observed after failure of treatment with currently available NNRTIs. This study will provide an assessment of safety and a preliminary assessment of the efficacy of DPC 083 when administered at a dose of 100 mg once daily in combination with 2 NRTIs, in a population of HIV-1-infected patients who are failing treatment with an NNRTI-containing regimen.
Patients receive DPC 083 once daily in combination with 2 NRTIs. The 2 NRTIs are selected by the investigators, based on HIV-1 genotyping results. Analyses for patient safety and drug efficacy are done at Weeks 8, 24, and 48 using results from clinical laboratory tests and physical exams. Patients continue to receive DPC 083 and NRTIs until the last patient enrolled in the study completes 48 weeks of treatment. Patients return for post-therapy follow-up visits at 1 and 3 months following early termination or study completion. Some patients may participate in a substudy which evaluates changes in HIV-1 levels in cerebrospinal fluid (CSF).
- Conditions
- HIV Infections
- Being tested
- DPC 083
- Keywords
- HIV-1, Drug Therapy, Combination, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPC 083Drug
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 2
- Primary purpose
- Treatment
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Dupont Applied Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Stanford, Principal investigatorDaniel Berger, Principal investigatorDaniel Seekins, Principal investigatorCharles Walworth, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007449
- Sponsor's protocol ID
- 314A
- Other IDs
- DPC 083-203
- Status last verified
- Jun 2002
- First submitted
- 19 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
- A Phase II, Open Label, Multicenter Study to Assess the Safety and Efficacy of 100 Mg DPC 083 Once Daily in Combination With Nucleoside Analogue Reverse Transcriptase Inhibitors in HIV-1-Infected Subjects Who Are Failing Treatment With a Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Regimen
- ClinicalTrials.gov ID
- NCT00007449
- Acronym / sponsor ID
- 314A
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Therapy, Combination, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Dupont Applied BiosciencesIndustry (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 the safety and tolerability of the study drug DPC 083 combined with 2 nucleoside reverse transcriptase inhibitors (NRTIs) in HIV-infected patients who are failing their nonnucleoside reverse transcriptase inhibitor (NNRTI) treatment.
In some studies DPC 083 (an NNRTI) has been found to lower the amount of HIV in the blood (viral load), where drug-resistant types of HIV were not lowered by other NNRTIs. This study will attempt to determine how safe DPC 083 is when it is taken in combination with 2 NRTIs.
Detailed description
Preclinical and human pharmacokinetic data suggest that DPC 083 can be administered once daily and provide trough plasma concentrations of free drug that will suppress replication of HIV-1, including strains containing key resistance mutations observed after failure of treatment with currently available NNRTIs. This study will provide an assessment of safety and a preliminary assessment of the efficacy of DPC 083 when administered at a dose of 100 mg once daily in combination with 2 NRTIs, in a population of HIV-1-infected patients who are failing treatment with an NNRTI-containing regimen.
Patients receive DPC 083 once daily in combination with 2 NRTIs. The 2 NRTIs are selected by the investigators, based on HIV-1 genotyping results. Analyses for patient safety and drug efficacy are done at Weeks 8, 24, and 48 using results from clinical laboratory tests and physical exams. Patients continue to receive DPC 083 and NRTIs until the last patient enrolled in the study completes 48 weeks of treatment. Patients return for post-therapy follow-up visits at 1 and 3 months following early termination or study completion. Some patients may participate in a substudy which evaluates changes in HIV-1 levels in cerebrospinal fluid (CSF).
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)
- Have HIV infection.
- Are at least 18 years old.
- Weigh at least 50 kg.
- Have documented evidence of virologic failure.
- Have screening HIV genotype done while receiving NNRTI treatment, or within 2 weeks after stopping the treatment.
Key exclusion criteria (20 listed)
- Had virologic failure of any treatment containing an HIV protease inhibitor drug.
- Had virologic failure of more than 1 treatment containing an NNRTI drug.
- Have participated in any study using DPC 083.
- Were treated with any experimental NNRTI.
- Have cancer that requires systemic therapy.
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 |
|---|---|---|
| DPC 083 | 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.
James Stanford principal investigator
Daniel Berger principal investigator
Daniel Seekins principal investigator
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DPC 083 in people with HIV Infections, run by Dupont Applied Biosciences at 5 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 20 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 5 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 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?
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.