Safety and Effectiveness of a Combination Anti-HIV Drug Treatment
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)
2 other identifiers
interventional
150
1 country
23
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv-infections
Started Jul 1999
Shorter than P25 for phase_4 hiv-infections
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1999
CompletedFirst Submitted
Initial submission to the registry
April 4, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
August 1, 2000
April 4, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (23)
East Bay AIDS Ctr
Berkeley, California, 94705, United States
Pacific Oaks Research
Beverly Hills, California, 90211, United States
Altamed Medical Health Services
Los Angeles, California, 90022, United States
St Lukes Medical Group
San Diego, California, 92101, United States
Pacific Horizons Med Group
San Francisco, California, 94115, United States
Gary Richmond MD
Fort Lauderdale, Florida, 33316, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Saint Josephs Comprehensive Research Institute
Tampa, Florida, 33607, United States
Northstar Med Clinic
Chicago, Illinois, 60657, United States
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536, United States
Boston Med Ctr / Evans - 556
Boston, Massachusetts, 021182393, United States
CRI of New England
Brookline, Massachusetts, 02445, United States
Univ of Nebraska Medical Ctr
Omaha, Nebraska, 681985400, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019, United States
Univ of North Carolina / Infectious Disease Division
Chapel Hill, North Carolina, 27599, United States
Univ of NC Infectious Diseases
Wilmington, North Carolina, 28402, United States
Anderson Clinical Research Inc
Reading, Pennsylvania, 19604, United States
Miriam Hosp
Providence, Rhode Island, 02906, United States
Burnside Clinic
Columbia, South Carolina, 29206, United States
Univ of Texas Med Branch
Galveston, Texas, 77555, United States
Univ of Texas / Thomas Street Clinic
Houston, Texas, 77030, United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 4, 2000
First Posted
August 31, 2001
Study Start
July 1, 1999
Study Completion
October 1, 2000
Last Updated
June 24, 2005
Record last verified: 2000-08