Clareo Health | The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease
The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
In Part I, patients who have had prior AZT therapy receive either nevirapine or placebo in combination with AZT. In Part II, patients who are nucleoside naive receive either nevirapine or matching placebo. After 6 months, patients receive open-label nevirapine.
Age
13–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
