Alternative Dosing Strategy for Anti-HIV Drugs

NCT00059384 | Completed Phase 4

• 3 other identifiers: 2R01AI033835-08A15M01RR000400-3404203M01RR000400-34S1A20420ú
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Anti-HIV drugs are usually given to patients at fixed, standardized doses. This study will investigate alternative ways of dosing anti-HIV drugs to improve viral control. Study hypothesis: The optimal dosage regimen required to obtain the maximum benefit from antiretroviral therapy is achieved with strategies that control for pharmacokinetic and pharmacodynamic variability among patients.

Conditions

HIV Infections

Keywords

Treatment experienced; Therapeutic Drug Monitoring

Outcome Measures

Primary Outcomes (3)

• Ability of the concentration-controlled strategies to achieve and maintain target concentrations

• safety and tolerability of pharmacologic intensification

• ability of pharmacologic intensification to achieve and maintain a sustained suppression in plasma HIV RNA

Secondary Outcomes (2)

• Cross clade neutralizing antibody

• cellular immunity

Interventions

Concentration-controlled therapy BEHAVIORAL

Eligibility Criteria

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

You may qualify if:

• HIV infected
• Receiving therapy with 3 or more antiretroviral medications and and willing to continue this regimen
• Achieved a greater than 1 log10 reduction in plasma HIV-RNA from baseline within 8 weeks after the start of current therapy
• Current plasma HIV-RNA levels greater than 500 copies/mL and less than 10,000 copies/mL
• HIV infected
• Receiving antiretroviral therapy and have been determined to have had virologic failure
• Will or have been changed to a new antiretroviral regimen (addition of greater than one new antiretroviral agent), but have not received this new regimen for more than 4 weeks as of study entry
• HIV RNA of 2500 copies/mL or greater at screening

You may not qualify if:

• Concurrent investigational antiretroviral agent
• Malignancy, including Kaposi's sarcoma, requiring systemic chemotherapy
• Active opportunistic infection requiring therapy within 14 days prior to study entry
• Drug-resistant mutations that necessitate a change in antiretroviral regimen
• Active drug or alcohol use or dependence
• Certain laboratory abnormalities
• Pregnant or breastfeeding
• Known nonadherence with medications and scheduled clinic visits
• Any medical condition that, in the opinion of the investigators, would preclude successful completion of the study

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

MeSH Terms

Conditions

HIV Infections

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

• Courtney V. Fletcher, PharmD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 23, 2003
• First Posted: April 24, 2003
• Study Start: January 1, 2003
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: September 17, 2008

Record last verified: 2007-07

Locations

US (1)