HIV InfectionsPhase 1NCT00002427
Safety and Effectiveness of Combining Hydroxyurea (HU) With Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults
A Phase 1 study testing Hydroxyurea, Stavudine and Didanosine in people with HIV Infections, run by Research Institute for Genetic and Human Therapy at 18 sites in United States.
Trial summary
The purpose of this study is to compare the safety and effectiveness of 9 doses of HU in order to find the best dose of HU to use with ddI and d4T in fighting HIV infection. HU plus ddI plus d4T appears to be a suitable anti-HIV drug combination for long-term control of HIV. 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?
- Hydroxyurea, Stavudine and Didanosine
- How many people
- 225 participants
- Where
- 18 sitesUnited States
- Study dates
- May 1999to not given
- Phase
- Phase 1
- 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 HIV-positive.
- Have a viral load of 5,000 to 100,000 copies/ml.
- Are willing to stop all anti-HIV medications for at least 28 days before receiving study drugs.
- Are at least 18 years old.
Who cannot join
- Patients will not be eligible for this study if they:
- Have a history of opportunistic (AIDS-related) infection.
- Have a history of pancreatitis or other serious condition.
- Have any cancer that will require chemotherapy within the next 24 weeks.
- Are allergic to ddI or d4T.
- Have received an HIV vaccine within 28 days of study entry.
Show all 9Show fewer
- Have received a red blood cell transfusion within the past 60 days, or have had repeated transfusions at any time in the past.
- Abuse alcohol or drugs.
- Have received certain medications.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Albany Med College
Albany, New York, 122083479
IDC Research Initiative
Altamonte Springs, Florida, 32701
AIDS Research Consortium of Atlanta Inc
Atlanta, Georgia, 30308
New England Med Ctr
Boston, Massachusetts, 02111
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
Univ of Texas Med Branch
Galveston, Texas, 775550835
Montrose Clinic
Houston, Texas, 77006
Boulevard Comprehensive Care Ctr
Jacksonville, Florida, 32209
AIDS Healthcare Foundation
Los Angeles, California, 90027
Mt Vernon Hosp
Mount Vernon, New York, 10550
Coastal Carolina Research Ctr
Mt. Pleasant, South Carolina, 29464
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, 19104
Thomas Jefferson Univ
Philadelphia, Pennsylvania, 19107
San Francisco VA Med Ctr
San Francisco, California, 94121
Swedish Med Ctr
Seattle, Washington, 98122
Gary Blick MD
Stamford, Connecticut, 06901
Center for Quality Care
Tampa, Florida, 33609
Dr Bruce Rashbaum
Washington D.C., District of Columbia, 20037
About this study
Official title: A Phase I/II Study of the Safety and Antiretroviral Activity of Nine Hydroxyurea Regimens in Combination With ddI and d4T in Subjects With HIV Infection
The purpose of this study is to compare the safety and effectiveness of 9 doses of HU in order to find the best dose of HU to use with ddI and d4T in fighting HIV infection.
HU plus ddI plus d4T appears to be a suitable anti-HIV drug combination for long-term control of HIV. This combination can sharply decrease viral load (level of HIV in the body) with few side effects, making it easy to take.
Read the detailed description
The combination of HU plus ddI plus d4T appears to be suitable for long-term control of HIV in that it: (1) has a novel resistance/rebound profile demonstrating virus suppression even in the presence of ddI-resistant mutants; (2) can produce a pronounced fall in viral load; and (3) is well tolerated (over 200 patients have been treated for up to 3 years with minimal side effects).
Patients are stratified by antiretroviral experience: naive (no more than 2 weeks of therapy) versus experienced (more than 2 weeks). Patients must discontinue all antiretroviral therapy for at least 28 days prior to randomization to 1 of 9 HU treatment arms. Treatment arms are divided into 3 HU dose categories: very low, low, and medium. Within each category HU is administered daily on 3 different dosing schedules. Depending on viral load, patients on the very low and low dose arms may have the opportunity to intensify their HU dose at any time beyond Week 12, provided no Grade 3 or 4 HU-related toxicity is present (these patients are monitored for an additional 8 weeks following intensification). All patients receive ddI and d4T at the same doses every day. When 50% of patients have completed 24 weeks of treatment, an analysis is made to determine whether or not to continue the 52-week study without modifications. Patients are monitored periodically for changes in plasma HIV RNA, CD4 cell counts, weight, and symptoms.
- Conditions
- HIV Infections
- Being tested
- Hydroxyurea, Stavudine, Didanosine
- Keywords
- Didanosine, Dose-Response Relationship, Drug, Drug Therapy, Combination, Stavudine, Hydroxyurea, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
- Study startMay 1999
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 1
- Primary purpose
- Treatment
- Intervention model
- Factorial
- Enrolment
- 225 participants
Sponsor and investigators
- Lead sponsor
- Research Institute for Genetic and Human Therapy
- Sponsor type
- University, hospital or other
- Investigators
- Franco Lori, Study chairJulianna Lisziewicz, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002427
- Sponsor's protocol ID
- 304A
- Other IDs
- RIGHT 702
- Status last verified
- Aug 2000
- 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 Phase I/II Study of the Safety and Antiretroviral Activity of Nine Hydroxyurea Regimens in Combination With ddI and d4T in Subjects With HIV Infection
- ClinicalTrials.gov ID
- NCT00002427
- Acronym / sponsor ID
- 304A
- Conditions
- HIV Infections
- Keywords
- Didanosine, Dose-Response Relationship, Drug, Drug Therapy, Combination, Stavudine, Hydroxyurea, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants
- Lead sponsor
- Research Institute for Genetic and Human TherapyUniversity, hospital or other
- Study start
- May 1999
- 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 compare the safety and effectiveness of 9 doses of HU in order to find the best dose of HU to use with ddI and d4T in fighting HIV infection.
HU plus ddI plus d4T appears to be a suitable anti-HIV drug combination for long-term control of HIV. This combination can sharply decrease viral load (level of HIV in the body) with few side effects, making it easy to take.
Detailed description
The combination of HU plus ddI plus d4T appears to be suitable for long-term control of HIV in that it: (1) has a novel resistance/rebound profile demonstrating virus suppression even in the presence of ddI-resistant mutants; (2) can produce a pronounced fall in viral load; and (3) is well tolerated (over 200 patients have been treated for up to 3 years with minimal side effects).
Patients are stratified by antiretroviral experience: naive (no more than 2 weeks of therapy) versus experienced (more than 2 weeks). Patients must discontinue all antiretroviral therapy for at least 28 days prior to randomization to 1 of 9 HU treatment arms. Treatment arms are divided into 3 HU dose categories: very low, low, and medium. Within each category HU is administered daily on 3 different dosing schedules. Depending on viral load, patients on the very low and low dose arms may have the opportunity to intensify their HU dose at any time beyond Week 12, provided no Grade 3 or 4 HU-related toxicity is present (these patients are monitored for an additional 8 weeks following intensification). All patients receive ddI and d4T at the same doses every day. When 50% of patients have completed 24 weeks of treatment, an analysis is made to determine whether or not to continue the 52-week study without modifications. Patients are monitored periodically for changes in plasma HIV RNA, CD4 cell counts, weight, and symptoms.
Study design
- Primary purpose
- Treatment
- Intervention model
- Factorial
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are HIV-positive.
- Have a viral load of 5,000 to 100,000 copies/ml.
- Are willing to stop all anti-HIV medications for at least 28 days before receiving study drugs.
- Are at least 18 years old.
Key exclusion criteria (9 listed)
- Have a history of opportunistic (AIDS-related) infection.
- Have a history of pancreatitis or other serious condition.
- Have any cancer that will require chemotherapy within the next 24 weeks.
- Are allergic to ddI or d4T.
- Have received an HIV vaccine within 28 days of study entry.
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 |
|---|---|---|
| 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.
Franco Lori study chair
Julianna Lisziewicz study chair
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydroxyurea, Stavudine and Didanosine in people with HIV Infections, run by Research Institute for Genetic and Human Therapy at 18 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 5 inclusion and 9 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 18 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 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.
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.