Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to look at the safety and effectiveness of a pill called Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). In this study, Trizivir will be compared to Combivir plus abacavir.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: Abacavir; Dideoxynucleosides; Lamivudine; Lamivudine, zidovudine drug combination; Zidovudine

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are at least 18 years old.

• Are HIV-positive.

• Are currently receiving one of the following anti-HIV drug combinations: Combivir plus abacavir, Combivir plus abacavir plus a protease inhibitor, or Combivir plus abacavir plus a non-nucleoside reverse transcriptase inhibitor (NNRTI). Patients must have been taking this drug combination for at least the past 16 weeks. This also must be the first anti-HIV drug combination the patient has received.

• Have a viral load (level of HIV in the blood) less than or equal to 400 copies/ml.

• Have CD4+ cell count greater than 200 cells/mm3.

• Agree to use effective methods of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have been diagnosed with AIDS.

• Have a gastrointestinal disorder that makes it difficult for patients to absorb food or to take medications by mouth.

• Have hepatitis.

• Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease.

• Are allergic to any of the study drugs.

• Abuse alcohol or drugs.

• Will not be available for the entire 24-week study period.

• Are pregnant or breast-feeding.

• Have taken or will need to take certain medications, including radiation therapy, chemotherapy, drugs that affect the immune system (such as interleukin), an HIV vaccine, foscarnet, and hydroxyurea.

• Are enrolled in another experimental drug study.