Overview

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.