A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Lamivudine; Drug: Stavudine; Drug: Didanosine; Drug: Indinavir sulfate; Drug: Nevirapine

Study type: Interventional

Funder types: Other

Identifiers

NCT00002407

ATLANTIC STUDY

Details and patient eligibility

About

The purpose of this study is to see if it is safe and effective to give one of three different triple-drug combinations to HIV-infected patients who have never been treated with anti-HIV drugs.

Full description

In this open-label, strategic study patients are evaluated at Weeks 0, 1, 2, 4, 8, 12 to Week 48 after being treated on one of the following regimens:

Stavudine (d4T) + Didanosine (ddI) + Lamivudine (3TC) or d4T + ddI + Indinavir or d4T + ddI + Nevirapine.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients must have:

• Diagnosed asymptomatic HIV infection.
• HIV-1 RNA greater than 500 copies/ml.
• CD4+ T-cell count greater than 200/mm3.
• Never received antiretroviral therapy.

Exclusion Criteria

Co-existing Condition:

Excluded:

Severe non-HIV-related disease.

Patients with the following prior conditions are excluded:

History of neuropathy.

Prior Medication:

Excluded:

• Investigational drug within 1 month prior to study.
• Immunomodulatory drug within 1 month prior to study.

Prior Treatment:

Excluded:

• Radiation therapy within past month.
• Chemotherapy within past month.