Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00005017
First received: April 3, 2000
Last updated: June 23, 2005
Last verified: June 2001

April 3, 2000
June 23, 2005
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Complete list of historical versions of study NCT00005017 on ClinicalTrials.gov Archive Site
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Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received Treatment
A Phase IV, Open-Label, Randomized Study to Compare the Efficacy and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) for 96 Weeks in the Treatment of HIV-1 Infected Subjects Who Are Antiretroviral Therapy Naive

The purpose of this study is to see how effective and safe it is to give 1 of the 3 following treatments to patients who may not have received anti-HIV treatment: 1) lamivudine (3TC)/abacavir (ABC)/stavudine (d4T); 2) 3TC/ABC/efavirenz (EFV); or 3) 3TC/ABC/amprenavir (APV)/ritonavir (RTV).

Patients are randomized to initiate antiretroviral therapy in 1 of 3 treatment groups. Within each group they are stratified based on HIV-1 plasma RNA levels.

Group 1: Patients receive 3TC/ABC/d4T; Group 2: Patients receive 3TC/ABC/EFV; and Group 3: Patients receive 3TC/ABC/APV/RTV.

Treatment continues for 96 weeks. Blood samples are collected to measure plasma HIV RNA and CD4 counts and patients are assessed regularly. In the event of incomplete viral suppression or virologic failure, patients will be switched to secondary therapy.

Interventional
Phase 4
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Ritonavir
  • Drug: Abacavir sulfate
  • Drug: Amprenavir
  • Drug: Efavirenz
  • Drug: Lamivudine
  • Drug: Stavudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
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Inclusion Criteria

Patients may be eligible for this trial if they:

  • Are HIV-positive.
  • Are at least 18 years old.
  • Have a viral load of at least 5,000 copies/ml.
  • Have a CD4 count of at least 50 cells/mm3.
  • Agree to practice effective methods of birth control while on the study, if a woman.

Patients are not eligible for this trial if they:

Are pregnant or breast-feeding. Have ever taken anti-HIV drugs. (Less than 2 weeks of prior anti-HIV treatment is allowed.) Have a history of AIDS-defining opportunistic illness (except for Kaposi's sarcoma involving skin) within 45 days of the screening visit. Treatment for the illness must have been completed at least 30 days prior to screening.

Are enrolled in another study where the medication may interfere with the control of viral load in this study.

Have a serious medical condition such as diabetes or heart problems that would make it unsafe to be on this study.

Have a history of a severe nerve disease of the type that may cause muscle weakness.

Have had pancreatitis (inflamed pancreas) or hepatitis within 6 months of starting the study.

Have had radiation treatment or chemotherapy within 4 weeks prior to study entry, or think those treatments may be needed during the study period. Local treatment for Kaposi's sarcoma is allowed.

Have used certain medications, including vaccines, that interfere with the immune system within 4 weeks prior to study entry.

Have taken an HIV vaccine within 3 months prior to entry. Are taking St. John's wort. Have a history of being allergic to any of the study drugs.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005017
264N, ESS40001
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
June 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP