Virologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination With Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Unexplained temperature of 38.5 C or higher for 7 consecutive days, or chronic diarrhea defined as more than 3 liquid stools per day persisting for 15 days, within 30 days prior to study entry.

Proven or suspected acute hepatitis within 30 days prior to study entry.

Malignancy that requires systemic chemotherapy. NOTE:Patients with minimal Kaposi's sarcoma (KS) fewer than 5 cutaneous lesions and no visceral disease or tumor-associated edema) are allowed to enroll provided that they do not require systemic therapy.

Concurrent Medication:

Excluded:

Concurrent ZDV (for patients other than those rolling over from ACTG 306).

Any experimental antiretroviral agents or other experimental therapies.

Acute therapy for an infection or other medical illnesses within 14 days prior to study entry.

Recombinant erythropoietin (rEPO), G-CSF, or GM-CSF within 30 days prior to study entry.

Interferons, interleukins, or HIV vaccines within 30 days prior to study entry.

Rifampin, rifabutin, cisapride, triazolam, midazolam, terfenadine, astemizole, or loratadine, within 14 days prior to study entry.

Patients with the following prior conditions are excluded:

History of acute or chronic pancreatitis.

History of Grade 2 or higher bilateral peripheral neuropathy. \[AS PER AMENDMENT 12/19/97: Patients with Grade 2 or 3 peripheral neuropathy due to current use of ddI/3TC or d4T/3TC and who have a screening viral load above 500 copies/ml are eligible as they will be randomized to a regimen that does not contain an agent associated with peripheral neuropathy toxicity.\]

Prior Medication:

Excluded:

Prior NNRTI or protease inhibitor therapy.

Prior ZDV (for patients other than those rolling over from ACTG 306).

Previous induction or maintenance therapy with foscarnet.

What this study is about