Relationship of Viral Resistance Development to CD4 Monitoring Alone or With Viral Load Monitoring

NCT00434070 | Completed

• 2 other identifiers: 99990709307-I-N093
• Study Type: observational
• Target: 1,012
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine whether HIV-infected patients are more likely to develop resistance to antiretroviral therapy if their blood is not monitored for the number of viruses (viral load) in the body. A virus that changes (mutates) over time may become resistant to certain types of medicine. This resistance may affect future treatment options. This study will compare the amount of virus in the blood of HIV-infected patients who have been monitored for viral load with the amount of virus in the blood of patients who have not been monitored for viral load. For patients who have detectable virus, the type of resistance (mutations) of the virus will be determined by comparing the components of the virus with that of a virus that is known not to be resistant. HIV-infected patients 18 years of age or older who are being treated at the Infectious Diseases Institute at Mulago Hospital at Makerere University in Kampala, Uganda, may be eligible for this study. Participants are interviewed about the treatments they have received for HIV and how they usually take their anti-HIV drugs. They also have a blood sample drawn for research tests.

Conditions

Acquired Immunodeficiency Syndrome; Resistance

Keywords

HIV; Antiretrovial Therapy; Resistance; Monitoring; TAMS; Treatment Experienced

Eligibility Criteria

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

You may qualify if:

• Willing to provide individual informed consent.
• HIV positive. (HIV status will have been confirmed by recognized external testing centre (e.g., AIC) or if necessary by the IDI lab using Abbott Determine HIV1-2 plus STAT-PAK (Chembio Diagnostic Systems) rapid tests. Unigold (Trinity Biotech) is available for tie-breaker testing if necessary.
• Currently being followed at the Adult Infectious Disease Clinic.
• Patients who are aged 18 years or more.
• Patients who initiated ART therapy at the Adult Infectious Disease Clinic (First line ART regimens include either stavudine or zidovudine).
• Patients who were ART naive at ART initiation (from patient medical record).
• Patients who have been on ART for at least 36 months and no greater than 40 months.

You may not qualify if:

• Inability or unwillingness to provide individual informed consent.
• Patients currently admitted to Urgent Care facility (severely ill).
• Age less than 18 years.
• Presence of a documented infection within a period of 4 weeks from screening for enrollment.

Sponsors & Collaborators

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

Study Sites (1)

Infectious Diseases Institute

Kampala, Uganda

Location

Related Publications (3)

• Akileswaran C, Lurie MN, Flanigan TP, Mayer KH. Lessons learned from use of highly active antiretroviral therapy in Africa. Clin Infect Dis. 2005 Aug 1;41(3):376-85. doi: 10.1086/431482. Epub 2005 Jun 30.

  PMID: 16007536 BACKGROUND

• Deeks SG, Grant RM. Sustained CD4 responses after virological failure of protease inhibitor-containing therapy. Antivir Ther. 1999;4 Suppl 3:7-11.

  PMID: 16021865 BACKGROUND

• Weiss L, Burgard M, Cahen YD, Chaix ML, Laureillard D, Gilquin J, Piketty C, Viard JP, Kazatchkine MD, Girard PM, Rouzioux C. Immunological and virological features of HIV-infected patients with increasing CD4 cell numbers despite virological failure during protease inhibitor-based therapy. HIV Med. 2002 Jan;3(1):12-20. doi: 10.1046/j.1464-2662.2001.00095.x.

  PMID: 12059946 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Steven J Reynolds, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 9, 2007
• First Posted: February 12, 2007
• Study Start: February 7, 2007
• Study Completion: February 7, 2013
• Last Updated: December 12, 2019

Record last verified: 2013-02-07

Locations

UG (1)