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The Safety and Effectiveness of Retrovir Plus HIVID Combined With Either Nevirapine or Invirase in the Treatment of HIV Infection

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Saquinavir
Nevirapine
Zidovudine
Zalcitabine
Sponsored by
Parexel
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Nevirapine, Saquinavir

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Encouraged: PCP chemoprophylaxis for patients whose CD4 count falls below 200 cells/mm3 or who develop PCP on study. Allowed: Secondary prophylaxis with nonexperimental agents in patients who develop TB, Mycobacterium avium-intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection. Acyclovir for 21 days or less for acute treatment. Recombinant erythropoietin and G-CSF for grade 3 or worse anemia and neutropenia, respectively. Patients must have: HIV infection. CD4 count 200 - 500 cells/mm3. No prior antiretroviral therapy. Life expectancy of at least 48 weeks. Consent of parent or guardian if less than 18 years of age. NOTE: Participating centers are encouraged to enroll female patients. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Any grade 3 or greater toxicity. Symptoms of peripheral neuropathy. Malabsorption or severe chronic diarrhea. Inability to eat at least one meal daily because of chronic nausea, emesis, or abdominal or esophageal discomfort. Concurrent Medication: Excluded during the first 28 days of nevirapine administration: Augmentin and other antibiotics containing clavulanic acid. Excluded at any time: Dicumarol, warfarin, and other anticoagulant medications. Tolbutamide. Cimetidine. Erythromycin. Patients with the following prior conditions are excluded: History of acute or chronic pancreatitis. History of grade 2 or worse peripheral neuropathy from any cause. Prior Medication: Excluded: Any prior antiretroviral therapy. Excluded within 4 weeks prior to study entry: Immunomodulating agents such as systemic corticosteroids, IL-2, alpha-interferon, beta-interferon, or gamma-interferon. Immunotherapeutic vaccines. Cytotoxic chemotherapy. Erythromycin. Dicumarol, Coumadin / warfarin, and other anticoagulant medications. Phenobarbital. Amoxicillin / clavulanate. Ticarcillin / clavulanate. Tolbutamide. Erythromycin. Cimetidine. Prior Treatment: Excluded within 4 weeks prior to study entry: Non-local radiation therapy. Current alcohol or illicit drug use that would interfere with ability to comply with study requirements.

Sites / Locations

  • PAREXEL Intl Corp / InterCo Collaboration Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT00002347
Brief Title
The Safety and Effectiveness of Retrovir Plus HIVID Combined With Either Nevirapine or Invirase in the Treatment of HIV Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 1995
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Parexel

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Nevirapine, Saquinavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
225 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Saquinavir
Intervention Type
Drug
Intervention Name(s)
Nevirapine
Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Zalcitabine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Encouraged: PCP chemoprophylaxis for patients whose CD4 count falls below 200 cells/mm3 or who develop PCP on study. Allowed: Secondary prophylaxis with nonexperimental agents in patients who develop TB, Mycobacterium avium-intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection. Acyclovir for 21 days or less for acute treatment. Recombinant erythropoietin and G-CSF for grade 3 or worse anemia and neutropenia, respectively. Patients must have: HIV infection. CD4 count 200 - 500 cells/mm3. No prior antiretroviral therapy. Life expectancy of at least 48 weeks. Consent of parent or guardian if less than 18 years of age. NOTE: Participating centers are encouraged to enroll female patients. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Any grade 3 or greater toxicity. Symptoms of peripheral neuropathy. Malabsorption or severe chronic diarrhea. Inability to eat at least one meal daily because of chronic nausea, emesis, or abdominal or esophageal discomfort. Concurrent Medication: Excluded during the first 28 days of nevirapine administration: Augmentin and other antibiotics containing clavulanic acid. Excluded at any time: Dicumarol, warfarin, and other anticoagulant medications. Tolbutamide. Cimetidine. Erythromycin. Patients with the following prior conditions are excluded: History of acute or chronic pancreatitis. History of grade 2 or worse peripheral neuropathy from any cause. Prior Medication: Excluded: Any prior antiretroviral therapy. Excluded within 4 weeks prior to study entry: Immunomodulating agents such as systemic corticosteroids, IL-2, alpha-interferon, beta-interferon, or gamma-interferon. Immunotherapeutic vaccines. Cytotoxic chemotherapy. Erythromycin. Dicumarol, Coumadin / warfarin, and other anticoagulant medications. Phenobarbital. Amoxicillin / clavulanate. Ticarcillin / clavulanate. Tolbutamide. Erythromycin. Cimetidine. Prior Treatment: Excluded within 4 weeks prior to study entry: Non-local radiation therapy. Current alcohol or illicit drug use that would interfere with ability to comply with study requirements.
Facility Information:
Facility Name
PAREXEL Intl Corp / InterCo Collaboration Ctr
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02154
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Thompson M, Myers M, Salgo M, Rousseau F, Odorisio M, Warburg M. A master protocol to evaluate the safety and efficacy of multidrug combination antiretroviral therapy with zidovudine and zalcitabine with or without saquinavir or nevirapine for the treatment of HIV infection. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:109 (abstract no 242)
Results Reference
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The Safety and Effectiveness of Retrovir Plus HIVID Combined With Either Nevirapine or Invirase in the Treatment of HIV Infection

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