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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: Abacavir; Amprenavir; Indinavir; Lamivudine

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.