The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Nevirapine (Drug); Zidovudine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Boehringer Ingelheim Pharmaceuticals
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.
Clinical Details
Official title: A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Activity, Safety, and Tolerance of 1) 400 Mg Nevirapine in Combination With 500-600 Mg Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 3-24 Months of Prior Zidovudine Therapy and 200-500 CD4 Cells/mm3 and 2) 400 Mg Nevirapine Versus Nevirapine Placebo in Asymptomatic HIV-1 Nucleoside Naive Patients With 200-500 CD4 Cells/mm3
Study design: Treatment, Double-Blind, Safety Study
Detailed description:
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.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Saint Francis Mem Hosp, San Francisco, California 94109, United States
UCSD Treatment Ctr, San Diego, California 92103, United States
Wilmington Hosp, Wilmington, Delaware 19801, United States
Community Research Initiative of South Florida, Coral Gables, Florida 33146, United States
Goodgame Med Group, Maitland, Florida 32751, United States
Univ of Kansas School of Medicine, Wichita, Kansas 67214, United States
Chandler Med Ctr, Lexington, Kentucky 405360084, United States
Kansas City AIDS Research Consortium, Kansas City, Missouri 641082792, United States
Community Research Initiative on AIDS, New York, New York 10001, United States
Med College of Ohio, Toledo, Ohio 43699, United States
Associates Med and Mental Health, Tulsa, Oklahoma 74114, United States
Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, United States
Dr Alfred F Burnside Jr, Columbia, South Carolina 29204, United States
Houston Clinical Research Network, Houston, Texas 77006, United States
Nelson-Tebedo Community Clinic, Dallas, Texas 75219, United States
Univ of Utah School of Medicine, Salt Lake City, Utah 84132, United States
Infectious Disease Physicians Inc, Annandale, Virginia 22203, United States
Richmond AIDS Consortium, Richmond, Virginia 23219, United States
Additional Information
Related publications: Pollard R . Surrogate marker response to NVP/ZDV or ZDV in a blinded clinical trial: correlation to changes in HIV isolate phenotypic susceptibility to NVP and ZDV. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:113
Last updated: June 23, 2005
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