HIV InfectionsPhase 2NCT00002412
A Study of MKC-442 in Combination With Other Anti-HIV Drugs
A Phase 2 study testing Emivirine, Hydroxyurea and Stavudine in people with HIV Infections, run by Triangle Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give MKC-442 plus stavudine (d4T) plus didanosine (ddI) plus hydroxyurea. 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?
- Emivirine, Hydroxyurea and Stavudine
- How many people
- Not given
- Where
- 1 siteUnited 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
- Concurrent Medication:
- Allowed:
- Based on medical history, medical condition, prior use of antiretroviral drugs, and genotypic analysis of the predominant strain of HIV-1 isolated from the plasma, administration of a combination of two or more available antiretroviral agents by prescription may be given with MKC-442.
- Patient must have:
- HIV infection with HIV-1 RNA greater than or equal to 5,000 by Roche Amplicor method within 30 days of entry.
- A failed protease inhibitor-containing regimen.
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- Negative serum beta human chorionic gonadotropin test within 30 days of entry.
- Prior Medication:
- Allowed:
- Prior nucleoside reverse transcriptase and protease inhibitors.
- Cytotoxic chemotherapy more than 30 days prior to entry.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Malabsorption or severe chronic diarrhea within 30 days prior to entry, or inability to consume adequate oral intake because of chronic nausea, emesis, or abdominal or esophageal discomfort.
- Inadequately controlled seizure disorder.
- Known intolerance to stavudine, didanosine, and/or hydroxyurea.
- Acute and clinically significant medical event within 30 days of screening.
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- Any clinical or laboratory abnormality greater than Grade 3 toxicity, with the exception of laboratory values given.
- Concurrent Treatment:
- Excluded:
- Any experimental antiretroviral therapy or immunomodulators directed against HIV-1, e.g., IL-4, cyclosporine steroids at doses greater than 40 mg/day.
- Prior Medication:
- Excluded:
- Non-nucleoside reverse transcriptase inhibitor therapy.
- Prior Treatment:
- Excluded:
- Radiation therapy within 30 days of entry except to a local lesion.
- Transfusion of blood or blood products within 21 days of screening.
- Cytotoxic therapy within 3 months of study entry.
- Risk Behavior:
- Excluded:
- Active substance abuse that may interfere with compliance or protocol evaluations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind Study of MKC-442 Combined With Stavudine, Didanosine, and Hydroxyurea in HIV-Infected Patients Who Are Protease Inhibitor Experienced and Non-Nucleoside Reverse Transcriptase Inhibitor Naive
The purpose of this study is to see if it is safe and effective to give MKC-442 plus stavudine (d4T) plus didanosine (ddI) plus hydroxyurea.
Read the detailed description
Patients are randomized to receive either MKC-442 or placebo, along with stavudine(d4T), didanosine(ddI), and hydroxyurea. Patients will be treated and followed for 48 weeks.
- Conditions
- HIV Infections
- Being tested
- Emivirine, Hydroxyurea, Stavudine, Didanosine
- Keywords
- Didanosine, Drug Therapy, Combination, Stavudine, Hydroxyurea, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, MKC 442
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmivirineDrug
HydroxyureaDrug
StavudineDrug
DidanosineDrug
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
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Triangle Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002412
- Sponsor's protocol ID
- 292C
- Other IDs
- MKC-305
- Status last verified
- Apr 1999
- First submitted
- 2 Nov 1999
- 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 Randomized, Double-Blind Study of MKC-442 Combined With Stavudine, Didanosine, and Hydroxyurea in HIV-Infected Patients Who Are Protease Inhibitor Experienced and Non-Nucleoside Reverse Transcriptase Inhibitor Naive
- ClinicalTrials.gov ID
- NCT00002412
- Acronym / sponsor ID
- 292C
- Conditions
- HIV Infections
- Keywords
- Didanosine, Drug Therapy, Combination, Stavudine, Hydroxyurea, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, MKC 442
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Triangle PharmaceuticalsIndustry (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 see if it is safe and effective to give MKC-442 plus stavudine (d4T) plus didanosine (ddI) plus hydroxyurea.
Detailed description
Patients are randomized to receive either MKC-442 or placebo, along with stavudine(d4T), didanosine(ddI), and hydroxyurea. Patients will be treated and followed for 48 weeks.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Based on medical history, medical condition, prior use of antiretroviral drugs, and genotypic analysis of the predominant strain of HIV-1 isolated from the plasma, administration of a combination of two or more available antiretroviral agents by prescription may be given with MKC-442.
- HIV infection with HIV-1 RNA greater than or equal to 5,000 by Roche Amplicor method within 30 days of entry.
- A failed protease inhibitor-containing regimen.
- Negative serum beta human chorionic gonadotropin test within 30 days of entry.
- Prior nucleoside reverse transcriptase and protease inhibitors.
Key exclusion criteria (21 listed)
- Malabsorption or severe chronic diarrhea within 30 days prior to entry, or inability to consume adequate oral intake because of chronic nausea, emesis, or abdominal or esophageal discomfort.
- Inadequately controlled seizure disorder.
- Known intolerance to stavudine, didanosine, and/or hydroxyurea.
- Acute and clinically significant medical event within 30 days of screening.
- Any clinical or laboratory abnormality greater than Grade 3 toxicity, with the exception of laboratory values given.
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 |
|---|---|---|
| Emivirine | Drug | – |
| Hydroxyurea | Drug | – |
| Stavudine | Drug | – |
| Didanosine | 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 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 Phase 2 study testing Emivirine, Hydroxyurea and Stavudine in people with HIV Infections, run by Triangle Pharmaceuticals 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 11 inclusion and 21 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 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.
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.
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.