HIV InfectionsPhase 4NCT00005018
Safety and Effectiveness of a Combination Anti-HIV Drug Treatment
A Phase 4 study testing Hydroxyurea, Abacavir sulfate and Efavirenz in people with HIV Infections, run by Glaxo Wellcome at 23 sites in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give HIV-positive patients a combination of anti-HIV drugs (abacavir [ABC] plus efavirenz [EFV] plus didanosine [ddI]) with and without hydroxyurea (HU). Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Hydroxyurea, Abacavir sulfate and Efavirenz
- How many people
- 150 participants
- Where
- 23 sitesUnited States
- Study dates
- Jul 1999to Oct 2000
- Phase
- Phase 4
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are taking lamivudine (3TC) plus either zidovudine (ZDV) or stavudine (d4T). Patients may also be taking one or two protease inhibitors (PIs). (Patients will qualify if drug substitutions were made or if the drugs were stopped for up to 2 months under certain conditions.)
- Have a viral load of 400 copies/ml or more (treatment failure) after 16 weeks of this treatment.
- Have a viral load between 400 and 100,000 copies/ml.
- Have a CD4 cell count of 100 cells/mm3 or more.
- Have consent of a parent or guardian (if under 18).
- Agree to use a barrier form of birth control (such as condoms) during the study.
- Are at least 13 years old.
Who cannot join
- Patients will not be eligible for this study if they:
- Are unable to take medications by mouth.
- Have certain opportunistic (AIDS-related) infections or diseases.
- Have certain serious medical conditions such as diabetes or a disease of the liver, pancreas, or heart.
- Have a history of lymphoma.
- Have had peripheral neuropathy (a painful condition affecting the nervous system) within 2 months of study entry.
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- Have been taking anti-HIV drugs for more than 1.5 years without an effect on HIV levels.
- Have ever taken ABC, ddI, or a type of anti-HIV drug called an NNRTI (such as EFV).
- Are unable to complete all 48 weeks of the study or take all of the study drugs.
- Are receiving certain other investigational treatments.
- Are receiving radiation therapy or chemotherapy within 8 weeks of study entry, or plan to receive one of these treatments during the study. (Local treatment for Kaposi's sarcoma is allowed.)
- Are taking certain medications including those that might affect the immune system or HIV levels.
- Have received a vaccine within 8 weeks of study entry or an HIV vaccine within 3 months of study entry.
- Are pregnant or breast-feeding.
- Abuse alcohol or drugs.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
East Bay AIDS Ctr
Berkeley, California, 94705
Pacific Oaks Research
Beverly Hills, California, 90211
Boston Med Ctr / Evans - 556
Boston, Massachusetts, 021182393
CRI of New England
Brookline, Massachusetts, 02445
Univ of North Carolina / Infectious Disease Division
Chapel Hill, North Carolina, 27599
Northstar Med Clinic
Chicago, Illinois, 60657
Burnside Clinic
Columbia, South Carolina, 29206
Gary Richmond MD
Fort Lauderdale, Florida, 33316
Univ of Texas Med Branch
Galveston, Texas, 77555
Hampton Roads Med Specialists
Hampton, Virginia, 23666
Univ of Texas / Thomas Street Clinic
Houston, Texas, 77030
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536
Altamed Medical Health Services
Los Angeles, California, 90022
Univ of Miami School of Medicine
Miami, Florida, 331361013
Beth Israel Med Ctr
New York, New York, 10003
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019
Univ of Nebraska Medical Ctr
Omaha, Nebraska, 681985400
Miriam Hosp
Providence, Rhode Island, 02906
Anderson Clinical Research Inc
Reading, Pennsylvania, 19604
St Lukes Medical Group
San Diego, California, 92101
Pacific Horizons Med Group
San Francisco, California, 94115
Saint Josephs Comprehensive Research Institute
Tampa, Florida, 33607
Univ of NC Infectious Diseases
Wilmington, North Carolina, 28402
About this study
Official title: A Phase IV 48-Week, Randomized, Open-Label, Multicenter Trial of Abacavir (300mg BID)/Efavirenz (600mg QD)/Didanosine (400mg QD) +/- Hydroxyurea (500mg BID) in HIV-1 Infected Subjects Failing Initial Therapy With 3TC/ZDV (or d4T) +/- Protease Inhibitor(s)
The purpose of this study is to see if it is safe and effective to give HIV-positive patients a combination of anti-HIV drugs (abacavir [ABC] plus efavirenz [EFV] plus didanosine [ddI]) with and without hydroxyurea (HU).
Read the detailed description
Patients are randomized into one of two treatment arms: ABC/EFV/ddI or ABC/EFV/ddI/HU. In the second treatment arm, patients are further randomized to receive HU beginning at Baseline, when ABC/EFV/ddI is started, or at Week 8. Delaying HU may help offset the cytopenic effect of HU, as reflected in a blunted CD4 cell response. Patients are stratified according to their screening plasma HIV-1 RNA level (400 to 10,000 copies/ml and more than 10,000 to 100,000 copies/ml). Participants in the study receive study-related exams, lab tests, and study medications at no cost over the 48-week treatment period. The safety and effectiveness of the non-protease inhibitor rescue therapy is evaluated routinely by measuring viral load and the CD4 cell count, as well as the side effects caused by the medications. All of the medications are approved by the FDA and are not considered investigational.
- Conditions
- HIV Infections
- Being tested
- Hydroxyurea, Abacavir sulfate, Efavirenz, Didanosine
- Keywords
- HIV-1, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine, HIV Protease Inhibitors, Hydroxyurea, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir, efavirenz
- 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
Abacavir sulfateDrug
EfavirenzDrug
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 startJul 1999
- Study completionOct 2000
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 4
- Primary purpose
- Treatment
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005018
- Sponsor's protocol ID
- 238R
- Other IDs
- NZTA4008
- Status last verified
- Aug 2000
- First submitted
- 4 Apr 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 IV 48-Week, Randomized, Open-Label, Multicenter Trial of Abacavir (300mg BID)/Efavirenz (600mg QD)/Didanosine (400mg QD) +/- Hydroxyurea (500mg BID) in HIV-1 Infected Subjects Failing Initial Therapy With 3TC/ZDV (or d4T) +/- Protease Inhibitor(s)
- ClinicalTrials.gov ID
- NCT00005018
- Acronym / sponsor ID
- 238R
- Conditions
- HIV Infections
- Keywords
- HIV-1, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine, HIV Protease Inhibitors, Hydroxyurea, RNA, Viral
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Glaxo WellcomeIndustry (pharma, biotech, devices)
- Study start
- Jul 1999
- Study completion
- Oct 2000
- 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 HIV-positive patients a combination of anti-HIV drugs (abacavir [ABC] plus efavirenz [EFV] plus didanosine [ddI]) with and without hydroxyurea (HU).
Detailed description
Patients are randomized into one of two treatment arms: ABC/EFV/ddI or ABC/EFV/ddI/HU. In the second treatment arm, patients are further randomized to receive HU beginning at Baseline, when ABC/EFV/ddI is started, or at Week 8. Delaying HU may help offset the cytopenic effect of HU, as reflected in a blunted CD4 cell response. Patients are stratified according to their screening plasma HIV-1 RNA level (400 to 10,000 copies/ml and more than 10,000 to 100,000 copies/ml). Participants in the study receive study-related exams, lab tests, and study medications at no cost over the 48-week treatment period. The safety and effectiveness of the non-protease inhibitor rescue therapy is evaluated routinely by measuring viral load and the CD4 cell count, as well as the side effects caused by the medications. All of the medications are approved by the FDA and are not considered investigational.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Are taking lamivudine (3TC) plus either zidovudine (ZDV) or stavudine (d4T). Patients may also be taking one or two protease inhibitors (PIs). (Patients will qualify if drug substitutions were made or if the drugs were stopped for up to 2 months under certain conditions.)
- Have a viral load of 400 copies/ml or more (treatment failure) after 16 weeks of this treatment.
- Have a viral load between 400 and 100,000 copies/ml.
- Have a CD4 cell count of 100 cells/mm3 or more.
- Have consent of a parent or guardian (if under 18).
Key exclusion criteria (15 listed)
- Are unable to take medications by mouth.
- Have certain opportunistic (AIDS-related) infections or diseases.
- Have certain serious medical conditions such as diabetes or a disease of the liver, pancreas, or heart.
- Have a history of lymphoma.
- Have had peripheral neuropathy (a painful condition affecting the nervous system) within 2 months 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 | – |
| Abacavir sulfate | Drug | – |
| Efavirenz | 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.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydroxyurea, Abacavir sulfate and Efavirenz in people with HIV Infections, run by Glaxo Wellcome at 23 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 15 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 23 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.