Safety and Effectiveness of a Combination Anti-HIV Drug Treatment

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005018
• Other study ID #: 238R
• Secondary ID: NZTA4008
• Status: Completed
• Phase: Phase 4
• First received: April 4, 2000
• Last updated: June 23, 2005
• Start date: July 1999
• Est. completion date: October 2000

Study information

• Verified date: August 2000
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Hydroxyurea

• Abacavir sulfate

• Efavirenz

• Didanosine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,