Clinical trial NCT00005018: Safety and Effectiveness of a Combination Anti-HIV Drug Treatment
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
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
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 150
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

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