A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly

NCT00001122 | Completed Phase 2

• 2 other identifiers: AIEDRP AI-05-003AEHIV 003: MAT
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to see if observed therapy can help HIV-positive patients stick to their anti-HIV medication schedule. Observed therapy means that a nurse will watch patients take their medications to make sure that they take them correctly. It is very important that HIV-positive patients take their anti-HIV medications correctly so they get the best possible benefit from them. Taking the drugs correctly, called "adherence," may keep HIV virus levels in the blood (viral load) low for a longer time. Adherence can also slow the development of drug resistance, and this is especially important in patients with early HIV infection who are just beginning treatment. However, anti-HIV medication schedules are often complicated, and many patients have difficulty remembering to take their drugs at the correct time. This study will look at the effectiveness of a plan to help patients with this problem.

Conditions

HIV Infections

Keywords

Didanosine; Drug Therapy, Combination; Stavudine; HIV Protease Inhibitors; CD4 Lymphocyte Count; Nelfinavir; Reverse Transcriptase Inhibitors; Self Care; Anti-HIV Agents; Viral Load; efavirenz; Treatment Naive

Interventions

Nelfinavir mesylate DRUG

Efavirenz DRUG

Stavudine DRUG

Didanosine DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be eligible for this study if they:
• Are HIV-positive.
• Are at least 13 years old (consent is required if you are under 18).
• Have a CD4 count of at least 200 cells/mm3 within 30 days of study entry.
• Have never taken anti-HIV drugs.
• Agree to practice effective methods of birth control.

You may not qualify if:

• Patients will not be eligible for this study if they:
• Have cancer (except for Kaposi's sarcoma) that requires treatment.
• Have a history of hepatitis or pancreatitis.
• Have peripheral neuropathy.
• Have an alcohol abuse problem.
• Are pregnant or breast-feeding.
• Are taking certain medications, such as rifabutin, rifampin, interleukin, or chemotherapy.

Sponsors & Collaborators

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

Study Sites (2)

UCSD

San Diego, California, 92103, United States

Location

Univ of Texas Southwestern Med Ctr

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Nelfinavir; efavirenz; Stavudine; Didanosine

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

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Inosine; Purine Nucleosides; Purines; Ribonucleosides

Study Officials

• Susan Little

  PRINCIPAL INVESTIGATOR

• Diane Havlir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Primary Completion: October 1, 2003
• Last Updated: March 2, 2011

Record last verified: 2005-01

Locations

US (2)