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

Status unconfirmed · Phase 4

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00005017

Run by

Glaxo Wellcome

People needed

300

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Jaime Hernandez — Research Triangle Park, North Carolina, United States

Full record on ClinicalTrials.gov

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