Safety and Effectiveness of a Combination Anti-HIV Drug Treatment

Completed · Phase 4

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00005018

Run by

Glaxo Wellcome

People needed

150

Starts

1999-07-01

Expected to finish

2000-10-01

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• East Bay AIDS Ctr — Berkeley, California, United States
• Pacific Oaks Research — Beverly Hills, California, United States
• Altamed Medical Health Services — Los Angeles, California, United States
• St Lukes Medical Group — San Diego, California, United States
• Pacific Horizons Med Group — San Francisco, California, United States
• Gary Richmond MD — Fort Lauderdale, Florida, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Saint Josephs Comprehensive Research Institute — Tampa, Florida, United States
• Northstar Med Clinic — Chicago, Illinois, United States
• Univ of Kentucky Med Ctr — Lexington, Kentucky, United States
• Boston Med Ctr / Evans - 556 — Boston, Massachusetts, United States
• CRI of New England — Brookline, Massachusetts, United States
• Univ of Nebraska Medical Ctr — Omaha, Nebraska, United States
• Beth Israel Med Ctr — New York, New York, United States
• Saint Luke's - Roosevelt Hosp Ctr — New York, New York, United States
• Univ of North Carolina / Infectious Disease Division — Chapel Hill, North Carolina, United States
• Univ of NC Infectious Diseases — Wilmington, North Carolina, United States
• Anderson Clinical Research Inc — Reading, Pennsylvania, United States
• Miriam Hosp — Providence, Rhode Island, United States
• Burnside Clinic — Columbia, South Carolina, United States
• Univ of Texas Med Branch — Galveston, Texas, United States
• Univ of Texas / Thomas Street Clinic — Houston, Texas, United States
• Hampton Roads Med Specialists — Hampton, Virginia, United States

Full record on ClinicalTrials.gov

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