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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborators: |
Bristol-Myers Squibb Glaxo Wellcome |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000770 |
Purpose
To assess the safety and toxicity of zidovudine (AZT)/didanosine (ddI) versus AZT/ddI combined with nevirapine in HIV-infected patients, and to obtain preliminary anti-HIV activity data using immunologic and virologic markers.
Previous in vitro studies suggest that HIV that has already developed resistance to AZT and ddI is less able to develop resistance to nevirapine, a non-nucleoside reverse transcriptase inhibitor. Thus, convergent combination therapy with these three drugs in HIV-infected patients may prove more effective.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Nevirapine Drug: Zidovudine Drug: Didanosine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Pharmacokinetics Study |
| Official Title: | A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine |
| Estimated Enrollment: | 400 |
Previous in vitro studies suggest that HIV that has already developed resistance to AZT and ddI is less able to develop resistance to nevirapine, a non-nucleoside reverse transcriptase inhibitor. Thus, convergent combination therapy with these three drugs in HIV-infected patients may prove more effective.
Patients are randomized to receive AZT/ddI plus either nevirapine or placebo daily for 48 weeks, with possible extension for at least 12 weeks. At eight participating sites, ACTG 808 and 809 will be conducted as virologic and pharmacokinetic substudies.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Concurrent Treatment:
Allowed:
Prior Medication: Required:
Patients must have:
Exclusion Criteria
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded at any time:
Prior non-nucleoside reverse transcriptase inhibitors (NVP; L697,611; TIBO; atevirdine).
Excluded within 14 days prior to study entry:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Univ of California / San Diego Treatment Ctr | |
| San Diego, California, United States, 921036325 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| San Francisco AIDS Clinic / San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| Summitt Med Ctr / San Francisco Gen Hosp | |
| Oakland, California, United States, 94609 | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| Highland Gen Hosp / San Francisco Gen Hosp | |
| Oakland, California, United States, 946021018 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| United States, Illinois | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| Cook County Hosp | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| United States, Iowa | |
| Univ of Iowa Hosp and Clinic | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Massachusetts | |
| Harvard (Massachusetts Gen Hosp) | |
| Boston, Massachusetts, United States, 02114 | |
| Beth Israel Deaconess Med Ctr | |
| Boston, Massachusetts, United States, 02215 | |
| Beth Israel Deaconess - West Campus | |
| Boston, Massachusetts, United States, 02215 | |
| Boston Med Ctr | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Minnesota | |
| Univ of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| St Paul Ramsey Med Ctr | |
| St Paul, Minnesota, United States, 55101 | |
| Hennepin County Med Clinic | |
| Minneapolis, Minnesota, United States, 55415 | |
| United States, Nebraska | |
| Univ of Nebraska Med Ctr | |
| Omaha, Nebraska, United States, 681985130 | |
| United States, New York | |
| Montefiore Drug Treatment Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| Montefiore Family Health Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| Samaritan Village Inc / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Jack Weiler Hosp / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10465 | |
| City Hosp Ctr at Elmhurst / Mount Sinai Hosp | |
| Elmhurst, New York, United States, 11373 | |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |
| Bronx, New York, United States, 10461 | |
| Montefiore Med Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| Cornell Univ Med Ctr | |
| New York, New York, United States, 10021 | |
| Saint Clare's Hosp and Health Ctr | |
| New York, New York, United States, 10019 | |
| North Central Bronx Hosp / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| Comprehensive Health Care Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| United States, North Carolina | |
| Carolinas Med Ctr | |
| Charlotte, North Carolina, United States, 28203 | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| Moses H Cone Memorial Hosp | |
| Greensboro, North Carolina, United States, 27401 | |
| Wake County Dept of Health | |
| Raleigh, North Carolina, United States, 27610 | |
| United States, Ohio | |
| Univ of Cincinnati | |
| Cincinnati, Ohio, United States, 452670405 | |
| United States, Pennsylvania | |
| Univ of Pennsylvania at Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Thomas Jefferson Univ Hosp | |
| Philadelphia, Pennsylvania, United States, 191075098 | |
| Girard Med Ctr | |
| Philadelphia, Pennsylvania, United States, 191046073 | |
| Study Chair: | D'Aquila R | |
| Study Chair: | Hirsch M |
More Information
| Study ID Numbers: | ACTG 241 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000770 History of Changes |
| Health Authority: | United States: Federal Government |
|
Didanosine Drug Therapy, Combination Acquired Immunodeficiency Syndrome |
AIDS-Related Complex Zidovudine Nevirapine |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Nevirapine Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |