|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Parexel |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002347 |
Purpose
To evaluate the tolerance and immunologic and virologic effects of multidrug combinations of antiretrovirals in patients with HIV infection. Specifically, to evaluate zidovudine/zalcitabine ( AZT / ddC ) alone or in combination with either nevirapine or saquinavir ( Ro 31-8959 ).
Administration of three-drug combinations for treatment of HIV infection is preferred over monotherapy or duotherapy. A system has been designed to rapidly evaluate current multidrug combinations of antiretrovirals and allow the addition of new agents as they become available.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Saquinavir Drug: Nevirapine Drug: Zidovudine Drug: Zalcitabine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Master Protocol to Evaluate the Safety and Efficacy of Multi-Drug Combination Antiretroviral Therapy for the Treatment of HIV Infection: Retrovir/HIVID/Nevirapine and Retrovir/HIVID/Invirase |
| Estimated Enrollment: | 225 |
Administration of three-drug combinations for treatment of HIV infection is preferred over monotherapy or duotherapy. A system has been designed to rapidly evaluate current multidrug combinations of antiretrovirals and allow the addition of new agents as they become available.
Patients are randomized to receive AZT/ddC either alone or in combination with nevirapine or Ro 31-8959 for a minimum of 48 weeks. Patients are followed at weeks 2 and 4 and every 4 weeks thereafter.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Encouraged:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded during the first 28 days of nevirapine administration:
Excluded at any time:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Excluded within 4 weeks prior to study entry:
Prior Treatment:
Excluded within 4 weeks prior to study entry:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00002347 History of Changes |
| Other Study ID Numbers: | 229C, ICC 001 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Zalcitabine Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Zidovudine Nevirapine Saquinavir |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zalcitabine Zidovudine Nevirapine |
Saquinavir Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents HIV Protease Inhibitors Protease Inhibitors |