The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease

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

Summary

PRIMARY: To compare the effect of nevirapine versus placebo alone or in combination with zidovudine (AZT) on CD4 T-cell count and percentage after 3 and 6 months of treatment. To evaluate the safety and tolerance of nevirapine alone or in combination with AZT.

SECONDARY: To compare the effects of the various treatment combinations on virologic and immunologic markers.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Nevirapine; Zidovudine

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• PCP prophylaxis (trimethoprim-sulfamethoxazole, dapsone, or aerosolized pentamidine), at the discretion of the investigator.

• Antifungal prophylaxis with oral fluconazole or ketoconazole.

• Antiviral prophylaxis for herpes simplex virus with <= 1000 mg/day oral acyclovir.

• Dilantin for prevention and treatment of seizures.

Patients must have:

• Asymptomatic HIV-1 infection, with positive serum antibody to HIV-1 as determined by ELISA or Western blot.

• CD4 count 200-500 cells/mm3 within 4-28 days prior to study entry.

• No conditions indicative of AIDS.

• None of the constitutional symptoms that are specifically excluded.

• Prior AZT for 3-24 months (amended 04/04/94) immediately prior to study entry (Part I) OR no prior AZT (Part II).

• Consent of parent or guardian if less than 18 years of age.

NOTE:

• Co-enrollment in a protocol involving another investigational drug or biologic is not permitted.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Malignancy other than limited cutaneous basal cell carcinoma.

• Psychiatric condition sufficient to impair compliance with protocol requirements.

Concurrent Medication:

Excluded:

• Investigational drugs other than study drugs.

• Systemic glucocorticoids and steroid hormones.

• Dicumarol, warfarin, and other anticoagulant medications.

• Cimetidine.

• Tolbutamide.

• Doxycycline.

• Chloramphenicol.

• Phenobarbital and other barbiturates.

• Foscarnet.

• Erythromycin.

• Amoxicillin-clavulanate (Augmentin).

• Ticarcillin clavulanate (Timentin).

• Biologic response modifiers (alpha interferon, IL-2, immune modulators).

Patients with the following condition are excluded:

History of other clinically important disease (i.e., one that precludes participation in the study).

Prior Medication:

Excluded:

• Antiretroviral medications other than AZT.

Excluded within 4 weeks prior to study entry:

• Immunosuppressive or cytotoxic drugs or other experimental drugs.

• Systemic glucocorticoids and steroid hormones.

• Dicumarol, warfarin, and other anticoagulant medications.

• Cimetidine.

• Tolbutamide.

• Doxycycline.

• Chloramphenicol.

• Phenobarbital and other barbiturates.

• Foscarnet.

• Erythromycin.

• Amoxicillin-clavulanate (Augmentin).

• Ticarcillin clavulanate (Timentin).

• Biologic response modifiers (alpha interferon, IL-2, immune modulators).

Required (for patients in Part I):

• Prior AZT at 500-600 mg daily for at least 3 months but not more than 24 months immediately prior to study entry.

Chronic use of alcohol or drugs sufficient to impair compliance with protocol requirements.