Safety and Effectiveness of the Drug DPC 083 in Combination With Nucleoside Analogue Reverse Transcriptase Inhibitors in HIV-1-Infected Patients Who Are Failing Treatment With Nonnucleoside Reverse Transcriptase Inhibitors

NCT00007449 | Unknown Phase 2

• 2 other identifiers: 314ADPC 083-203
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to determine the safety and tolerability of the study drug DPC 083 combined with 2 nucleoside reverse transcriptase inhibitors (NRTIs) in HIV-infected patients who are failing their nonnucleoside reverse transcriptase inhibitor (NNRTI) treatment. In some studies DPC 083 (an NNRTI) has been found to lower the amount of HIV in the blood (viral load), where drug-resistant types of HIV were not lowered by other NNRTIs. This study will attempt to determine how safe DPC 083 is when it is taken in combination with 2 NRTIs.

Conditions

HIV Infections

Keywords

HIV-1; Drug Therapy, Combination; RNA, Viral; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load

Interventions

DPC 083 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be eligible for this study if they:
• Have HIV infection.
• Are at least 18 years old.
• Weigh at least 50 kg.
• Have documented evidence of virologic failure.
• Have screening HIV genotype done while receiving NNRTI treatment, or within 2 weeks after stopping the treatment.
• Have a viral load (amount of HIV in the blood) of at least 1,000 copies/ml within 45 days prior to Day 1 of study.
• Are willing to use an effective barrier method of birth control during the study. Birth control agents taken by mouth or placed under the skin should not be used as the only method of birth control. If the patient stops taking the study drug, he or she should continue to use birth control for the following 3 months.

You may not qualify if:

• Patients will not be eligible for this study if they:
• Had virologic failure of any treatment containing an HIV protease inhibitor drug.
• Had virologic failure of more than 1 treatment containing an NNRTI drug.
• Have participated in any study using DPC 083.
• Were treated with any experimental NNRTI.
• Have cancer that requires systemic therapy.
• Have a history of blood clotting problems.
• Have attempted suicide or are in danger of hurting themselves.
• Used illegal injection drugs within 6 months of study entry.
• Do not expect to complete 12 months on the study.
• Have not met requirements for HIV genotyping results.
• Have any disease other than HIV infection or other medical problems that the researchers think may interfere with the study.
• Have difficulty swallowing capsules/tablets.
• Have had treatment with immunomodulatory agents such as interferons, interleukins, or thalidomide within 30 days prior to study entry.
• Are using or have used systemic drugs, including glucocorticoids, that suppress the immune system, for over 2 weeks. (Low levels of prednisone are allowed.)

Sponsors & Collaborators

• Dupont Applied Biosciences: lead

Study Sites (5)

AIDS Healthcare Foundation

Los Angeles, California, 90027, United States

Location

Orange Coast Med Group

Newport Beach, California, 92663, United States

Location

Bach and Godofsky

Bradenton, Florida, 34205, United States

Location

Saint Josephs Comprehensive Research Institute

Tampa, Florida, 33607, United States

Location

Northstar Med Clinic

Chicago, Illinois, 60657, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

DPC 083

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• James Stanford

  PRINCIPAL INVESTIGATOR

• Daniel Berger

  PRINCIPAL INVESTIGATOR

• Daniel Seekins

  PRINCIPAL INVESTIGATOR

• Charles Walworth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 19, 2000
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 2002-06

Locations

US (5)