A Study of a Combination of Four Drugs in Patients With Recent HIV Infection

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002233
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1999
  Purpose

The purpose of this study is to see if it is safe to give a combination of four anti-HIV drugs to patients recently infected with HIV who have never received anti-HIV treatment. The effects of this combination of drugs on the immune system and the level of HIV in the body are studied also. The four-drug combination includes lamivudine, abacavir, amprenavir, and indinavir.


Condition Intervention Phase
HIV Infections
Drug: Indinavir sulfate
Drug: Abacavir sulfate
Drug: Amprenavir
Drug: Lamivudine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, 48-Week, Uncontrolled, Open-Label Study Designed to Evaluate the Safety and Efficacy of Quadruple Antiretroviral Therapy (EPIVIR, Abacavir, Amprenavir, and Indinavir) in Subjects Acutely Infected With HIV-1

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 30
Detailed Description:

Patients receive a four-drug regimen consisting of two nucleoside reverse transcriptase inhibitors (3TC and abacavir) and two protease inhibitors (amprenavir and indinavir) for a minimum of 48 weeks. At specified time points, patients undergo physical assessments and efficacy evaluations which include plasma HIV-1 RNA measurements and CD4 cell counts. Depending on the immunologic and virologic status of the patient, further testing may be done to determine whether quadruple drug therapy can attain undetectable viral levels.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed with caution and/or careful monitoring:

  • Drugs which may interact at CYP3A4 (e.g., alprazolam, carbamazepine, codeine, clarithromycin, dapsone, diazepam, diltiazem, erythromycin, estrogens, fluvastatin, glucocorticoids, imipramine, lidocaine, lovastatin, nifedipine, phenobarbital, phenytoin, simvastatin, and warfarin).
  • Drugs that inhibit cytosolic alcohol dehydrogenase (e.g., ethanol, disulfiram, chlorzoxazone, chlorpromazine, isoniazid, and chloral hydrate).
  • Drugs known to affect renal tubular secretion (e.g., probenecid or cimetidine), cause liver toxicity, or induce myelosuppression.

Patients must have:

  • Documented and confirmed acute HIV-1 infection.
  • No prior exposure to antiretroviral treatment.
  • Ability to comply with the investigational nature of the study for a minimum of 48 weeks.
  • Consent of parent or guardian if under the age of 18.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • A clinical diagnosis of AIDS, excluding CD4+ cell counts less than 200/mm3.
  • A serious medical condition such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that, in the opinion of the investigator, compromises the safety of the patient.
  • Institutionalized or mentally disabled.
  • Inability to comply with the dosing schedule and protocol evaluations for reasons other than those specified.

Concurrent Medication:

Excluded:

  • Concurrent therapy with rifampin, rifabutin, terfenadine, astemizole, ketoconazole, itraconazole, cisapride, triazolam, midazolam, quinidine, amiodarone, and/or ergotamine/dihydroergotamine-containing regimens.
  • Foscarnet or therapy with other agents with documented in vitro or in vivo activity against HIV-1.
  • Medications known to induce or inhibit hepatic cytochrome P450 enzyme systems.
  • Vitamin E supplements.

Concurrent Treatment:

Excluded:

  • Dependence on blood transfusions.
  • Other investigational treatments.

Patients with the following prior conditions are excluded:

  • A history of clinically relevant pancreatitis or hepatitis within 6 months of study entry.
  • A history of inflammatory bowel disease or malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction that might interfere with drug absorption or render the patient unable to take oral medication.
  • An unexplained fever above 38.5 Celsius for more than 14 days within 30 days of study entry.
  • A history of coagulopathy.

Prior Medication:

Excluded:

  • Prior exposure to antiretroviral therapy.
  • Therapy with immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents or interferons, cytotoxic chemotherapeutic agents, or anti-oxidants within 30 days of study entry.

Prior Treatment:

Excluded:

- Radiation therapy within 30 days of study entry.

Risk Behavior:

Excluded:

Alcohol or illicit drug use which, in the opinion of the investigator, may interfere with ability to comply with the dosing schedule and protocol evaluations.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002233

Locations
United States, New York
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, United States, 10021
United States, Rhode Island
Miriam Hosp / Family Healthcare Ctr at SSTAR
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002233     History of Changes
Other Study ID Numbers: 264K, COLA 2012
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
HIV Protease Inhibitors
CD4 Lymphocyte Count
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:
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
HIV Protease Inhibitors
Indinavir
Amprenavir
Lamivudine
Reverse Transcriptase Inhibitors
Abacavir
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents

ClinicalTrials.gov processed this record on April 22, 2014