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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of a Combination Anti-HIV Drug Treatment  Safety and Effectiveness of a Combination Anti-HIV Drug Treatment
Safety and Effectiveness of a Combination Anti-HIV Drug Treatment
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: 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).
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 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. Exclusion Criteria 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.
Total Enrollment: 150
Location and Contact Information:
Burnside Clinic
Columbia, South Carolina, 29206
United States
Anderson Clinical Research Inc
Reading, Pennsylvania, 19604
United States
East Bay AIDS Ctr
Berkeley, California, 94705
United States
Altamed Medical Health Services
Los Angeles, California, 90022
United States
Miriam Hosp
Providence, Rhode Island, 02906
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536
United States
Saint Josephs Comprehensive Research Institute
Tampa, Florida, 33607
United States
Univ of NC Infectious Diseases
Wilmington, North Carolina, 28402
United States
Boston Med Ctr / Evans - 556
Boston, Massachusetts, 021182393
United States
St Lukes Medical Group
San Diego, California, 92101
United States
Gary Richmond MD
Ft. Lauderdale, Florida, 33316
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Pacific Horizons Med Group
San Francisco, California, 94115
United States
CRI of New England
Brookline, Massachusetts, 02445
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10019
United States
Northstar Med Clinic
Chicago, Illinois, 60657
United States
Pacific Oaks Research
Beverly Hills, California, 90211
United States
Univ of Nebraska Medical Ctr
Omaha, Nebraska, 681985400
United States
Univ of Texas Med Branch
Galveston, Texas, 77555
United States
Univ of North Carolina / Infectious Disease Division
Chapel Hill, North Carolina, 27599
United States
Univ of Texas / Thomas Street Clinic
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: 238R; NZTA4008
Study Start Date: July 1999
Record last reviewed: August 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005018
Other Hiv Infections Studies:
1. A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected with Both HIV and Hepatitis C Virus (HCV)
2. A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Recent HIV Infection
3. Safety and Effectiveness of Administering an HIV Vaccine in the Groin versus the Arm
4. Atazanavir for HIV Infected Individuals: An Early Access Program
5. A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 mg q 8 h Versus 1,200 mg q 12 h in Combination with Zidovudine and 3TC
Related Studies:
Other HIV Infections Clinical Trials
Other South Carolina Clinical Trials
Other Columbia Clinical Trials
Safety and Effectiveness of a Combination Anti-HIV Drug Treatment
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