A Study of the Safety and Effectiveness of Combination Anti-HIV Therapy in HIV-Infected Adults

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

Summary

The purpose of this study is to see if a certain combination of anti-HIV drugs is safe and effective in HIV-infected patients. The drug combination includes a tablet containing lamivudine and zidovudine (called Combivir) plus abacavir plus efavirenz.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Have HIV levels of 50,000 copies/ml or more within 21 days prior to starting treatment.

• Are at least 18 years of age.

• Are willing to use an effective method of birth control during the study.

• (This study has been changed. A CD4 cell count of 50/mm3 or more within 21 days prior to starting treatment is no longer required.)

Exclusion Criteria

Patients will not be eligible for this study if they:

• Are pregnant.

• Have AIDS.

• Cannot take medications by mouth.

• Have hepatitis and it is active.

• Are enrolled in other investigational drug studies.

• Are allergic to any of the study drugs.

• Have a serious medical condition, such as heart disease.

• Have ever taken certain anti-HIV drugs such as nonnucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs).

• Have ever had more than 7 days of treatment with a nucleoside reverse transcriptase inhibitor (NRTI). Patients should have no prior treatment with abacavir and no prior treatment with at least one of the following: lamivudine or zidovudine.

• Have had radiation therapy or chemotherapy within 4 weeks prior to study entry, or plan to have such therapy during the study.

• Have received medications that might affect the immune system, such as systemic corticosteroids, interleukins, vaccines, or interferons within 4 weeks prior to study entry.

• Have received an HIV vaccine within 3 months prior to study entry.

• Are taking foscarnet, hydroxyurea, or other drugs that work against HIV.

• Have taken certain medications such as astemizole, cisapride, dihydroergotamine, ergotamine, ganciclovir, interferon-alpha, midazolam, terfenadine, and triazolam within 21 days of study entry.

• Abuse alcohol or drugs.

• Are unable to complete the whole study.