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).

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Hydroxyurea  Drug: Abacavir sulfate  Drug: Efavirenz  Drug: Didanosine	Phase IV

Further Study Details: 

Expected Total Enrollment:  150

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

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.

California
      St Lukes Medical Group, San Diego,  California,  92101,  United States
      Pacific Horizons Med Group, San Francisco,  California,  94115,  United States
      Pacific Oaks Research, Beverly Hills,  California,  90211,  United States
      East Bay AIDS Ctr, Berkeley,  California,  94705,  United States
      Altamed Medical Health Services, Los Angeles,  California,  90022,  United States
Florida
      Univ of Miami School of Medicine, Miami,  Florida,  331361013,  United States
      Gary Richmond MD, Fort Lauderdale,  Florida,  33316,  United States
      Saint Josephs Comprehensive Research Institute, Tampa,  Florida,  33607,  United States
Illinois
      Northstar Med Clinic, Chicago,  Illinois,  60657,  United States
Kentucky
      Univ of Kentucky Med Ctr, Lexington,  Kentucky,  40536,  United States
Massachusetts
      CRI of New England, Brookline,  Massachusetts,  02445,  United States
      Boston Med Ctr / Evans - 556, Boston,  Massachusetts,  021182393,  United States
Nebraska
      Univ of Nebraska Medical Ctr, Omaha,  Nebraska,  681985400,  United States
New York
      Saint Luke's - Roosevelt Hosp Ctr, New York,  New York,  10019,  United States
      Beth Israel Med Ctr, New York,  New York,  10003,  United States
North Carolina
      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
Pennsylvania
      Anderson Clinical Research Inc, Reading,  Pennsylvania,  19604,  United States
Rhode Island
      Miriam Hosp, Providence,  Rhode Island,  02906,  United States
South Carolina
      Burnside Clinic, Columbia,  South Carolina,  29206,  United States
Texas
      Univ of Texas Med Branch, Galveston,  Texas,  77555,  United States
      Univ of Texas / Thomas Street Clinic, Houston,  Texas,  77030,  United States
Virginia
      Hampton Roads Med Specialists, Hampton,  Virginia,  23666,  United States

Study ID Numbers:  238R; NZTA4008
Record last reviewed:  August 2000
Last Updated:  October 13, 2004
Record first received:  April 4, 2000
ClinicalTrials.gov Identifier:  NCT00005018
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08