The Safety and Effectiveness of Retrovir Plus HIVID Combined With Either Nevirapine or Invirase in the Treatment of HIV Infection
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ClinicalTrials.gov Identifier: NCT00002347 |
Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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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 or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Saquinavir Drug: Nevirapine Drug: Zidovudine Drug: Zalcitabine | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 225 participants |
Masking: | Double |
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 |

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Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002347
United States, Massachusetts | |
PAREXEL Intl Corp / InterCo Collaboration Ctr | |
Waltham, Massachusetts, United States, 02154 |
ClinicalTrials.gov Identifier: | NCT00002347 |
Other Study ID Numbers: |
229C ICC 001 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | June 1995 |
Zalcitabine Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Zidovudine Nevirapine Saquinavir |
Infections Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Disease Attributes Pathologic Processes Blood-Borne Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Zidovudine Nevirapine Zalcitabine Saquinavir Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Antiviral Agents Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents Cytochrome P-450 CYP3A Inducers |