Completed

Quadruple Antiretroviral Therapy for Acute HIV-1 Infection

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Indinavir sulfate

+ Abacavir sulfate

+ Amprenavir

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 15 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00002233
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 15 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

7 inclusion criteria required to participate
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
Documented and confirmed acute HIV-1 infection
No prior exposure to antiretroviral treatment
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18 exclusion criteria prevent from participating
A clinical diagnosis of AIDS, excluding CD4+ cell counts less than 200/mm3
A history of clinically relevant pancreatitis or hepatitis within 6 months of study entry
A history of coagulopathy
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
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ

New York, United StatesOpen Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ in Google Maps

Miriam Hosp / Family Healthcare Ctr at SSTAR

Providence, United States
Completed2 Study Centers