Analysis of HIV Genetic Variation in Patients Before Beginning Highly Active Antiretroviral Therapy

NCT00009256 | Completed

• 2 other identifiers: 00011000-I-0110
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to gain knowledge about why drug therapy sometimes stops working in people infected with the human immunodeficiency virus (HIV). This occurs in 30 to 40% of patients treated with powerful antiretroviral drugs. The study will examine how the virus becomes resistant to drug treatment through mutations (changes) and how different mutations produce new variants that are resistant to more than one drug. HIV-infected patients 18 years and older who have not been treated with antiretroviral medications and who have a relatively stable amount of virus in their blood (viral load) may be eligible for this study. Pregnant or breastfeeding women may not participate. Candidates will be screened with blood tests to determine viral load and to study the genetics of the virus. Participants will be hospitalized at the NIH Clinical Center for 10 days for daily blood sampling. (In exceptional circumstances, the sampling may be done on an outpatient basis.) After discharge, patients will be followed by weekly visits for blood tests for a total of 120 days. When antiretroviral treatment begins, the patient may do one of the following:

1. 1.Continue on this study with antiretroviral treatment. Therapy will consist of D4T, 3TC, and efavirenz. Other drugs may be substituted for any of these that cannot be tolerated. HIV protease inhibitors will not be included in the regimen.
2. 2.Complete participation in this study and, if eligible, enroll in another NIH protocol (AVBIO).
3. 3.Begin standard antiretroviral therapy with a private physician.

Conditions

HIV Infection

Keywords

Quasispecies Variation; Genotyping; Phenotyping; Antiretroviral Therapy; Drug Naive Patients; HIV; Treatment Naive

Eligibility Criteria

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

You may qualify if:

• HIV infection documented by ELISA/WB.
• Viral load documented in our clinic as greater than or equal to 1000 copies RNA/ml plasma on one occasion.
• At least 18 years of age.
• For women of child-bearing potential, a negative serum pregnancy test is required within 14 days prior to enrollment.
• Able to provide written informed consent.

You may not qualify if:

• Absence of HIV infection within 8 weeks prior to entry, documented as a negative HIV ELISA and WB within 8 weeks of screening positive ELISA and WB.
• Use of immunosuppressants or cytotoxic agents, with the exception of corticosteroids.
• Prior antiretroviral therapy with nucleoside or non-nucleoside RT inhibitors or protease inhibitors defined as: any therapy in the last 5 years; any more than 4 days of protease inhibitors or NNRTIs ever taken; any more than 2 weeks of NRTIs ever taken.
• Psychiatric illness that in the opinion of the PI might interfere with study compliance.
• Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise patient safety.
• Refusal to practice safer sex practices or use precautions to prevent pregnancy (effective barrier birth control or abstinence).

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Barrie KA, Perez EE, Lamers SL, Farmerie WG, Dunn BM, Sleasman JW, Goodenow MM. Natural variation in HIV-1 protease, Gag p7 and p6, and protease cleavage sites within gag/pol polyproteins: amino acid substitutions in the absence of protease inhibitors in mothers and children infected by human immunodeficiency virus type 1. Virology. 1996 May 15;219(2):407-16. doi: 10.1006/viro.1996.0266.

  PMID: 8638406 BACKGROUND

• Birk M, Sonnerborg A. Variations in HIV-1 pol gene associated with reduced sensitivity to antiretroviral drugs in treatment-naive patients. AIDS. 1998 Dec 24;12(18):2369-75. doi: 10.1097/00002030-199818000-00005.

  PMID: 9875574 BACKGROUND

• Butto S, Argentini C, Mazzella AM, Iannotti MP, Leone P, Leone P, Nicolosi A, Rezza G. Dual infection with different strains of the same HIV-1 subtype. AIDS. 1997 Apr;11(5):694-6. No abstract available.

  PMID: 9108960 BACKGROUND

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 Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 25, 2001
• First Posted: January 26, 2001
• Study Start: April 13, 2000
• Study Completion: March 3, 2009
• Last Updated: July 2, 2017

Record last verified: 2009-03-03

Locations

US (1)