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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002324

Run by

Boehringer Ingelheim

People needed

250

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.
• 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:

Where it is running

• UCSD Treatment Ctr — San Diego, California, United States
• Saint Francis Mem Hosp — San Francisco, California, United States
• Wilmington Hosp — Wilmington, Delaware, United States
• Community Research Initiative of South Florida — Coral Gables, Florida, United States
• Goodgame Med Group — Maitland, Florida, United States
• Univ of Kansas School of Medicine — Wichita, Kansas, United States
• Chandler Med Ctr — Lexington, Kentucky, United States
• Kansas City AIDS Research Consortium — Kansas City, Missouri, United States
• Community Research Initiative on AIDS — New York, New York, United States
• Med College of Ohio — Toledo, Ohio, United States
• Associates Med and Mental Health — Tulsa, Oklahoma, United States
• Philadelphia FIGHT — Philadelphia, Pennsylvania, United States
• Dr Alfred F Burnside Jr — Columbia, South Carolina, United States
• Nelson-Tebedo Community Clinic — Dallas, Texas, United States
• Houston Clinical Research Network — Houston, Texas, United States
• Univ of Utah School of Medicine — Salt Lake City, Utah, United States
• Infectious Disease Physicians Inc — Annandale, Virginia, United States
• Richmond AIDS Consortium — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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