HIV Expression in Patients With Low Viral Load on Highly Active Antiretroviral Therapy (HAART)

NCT00043641 | Completed

• 2 other identifiers: 02023202-I-0232
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate low-level viral loads in HIV-infected patients taking highly active antiretroviral therapy (HAART). Although HAART reduces viral levels and restores immune function to some degree, it does not cure HIV infection. The virus persists even at levels below that which it can be detected. This study will examine where this residual virus comes from in order to better understand the infection and the effectiveness of therapies. In addition, the study will 1) evaluate the ability of a new test to detect the virus at low levels; and 2) determine whether adding the protease inhibitor Kaletra to the HAART treatment regimen for patients with a low viral load will further decrease their viral load. HIV-infected patients 18 years of age and older may be eligible for this study. Patients involved in the viral load test will be recruited from an NIAID HIV study in which they are already participating. Three groups of patients will be enrolled: those with a viral load of less than 50 copies/ml plasma, those with 51-500 copies/ml, and those with 501-5000 copies/ml. Patients involved in the Kaletra trial must have been taking HAART for 6 months or more and have less than 50 viral copies/ml plasma. They will be screened for this study with a history, physical examination, and routine laboratory tests. Participants in the viral load test evaluation will donate 70 ml of blood up to four times. No more than one sample will be collected per day. Participants in the Kaletra trial will have blood samples drawn on two successive days and will then be randomly assigned to one of two treatment groups. One group will begin Kaletra therapy (four capsules two times a day) immediately; the other will undergo observation for 4 weeks before starting Kaletra. Depending on what group they are in, patients will provide blood samples for viral load measurements and clinical samples according to the following schedule: Immediate Kaletra One sample each during weeks 1, 2, and 3, of therapy and two samples during week 4. Delayed Kaletra One sample each during weeks 1, 2, and 3 of observation and two samples during week 4. After starting therapy, one sample will be collected each week during weeks 1, 2, and 3 of therapy and two samples during week 4. In both groups, after the last dose of medicine on day 28, Kaletra therapy will be complete. At the end of therapy, additional blood will be collected for viral sampling as follows: one sample each during weeks 1, 2, and 3, and two samples during week 4 after Kaletra therapy.

Conditions

HIV Infections

Keywords

RT PCR; Antiretrovial Therapy; Drug Intensification; Ultra-low; Sequence; HIV; Treatment Experienced

Eligibility Criteria

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

You may qualify if:

• HIV-1 infection documented by HIV ELISA and WB
• Age greater than or equal to 18 years old
• Hemoglobin greater than or equal to 12 mg/dl within the last six weeks
• On HAART according to current DHHS guidelines.
• Most recent viral load (within the last 12 weeks):
• less than 50 by bDNA or RT-PCR (65 patients)
• by bDNA or RT-PCR (3 patients)
• ,000 by bDNA or RT-PCR (2 patients)

You may not qualify if:

• Any febrile illness (T greater than 38.0 degrees C) in the 3 weeks prior to blood draw.
• Samples from patients enrolled in the completed M98-863, M97-720 or AACTG 5201 study.
• HIV-1 infection documented by HIV ELISA and WB
• Age greater than or equal to 18 years old
• Hgb greater than or equal to 12 mg/dl
• CD4 greater than 200 cells/ micro liter and CD4% greater than 14% and not requiring prophylaxis for opportunistic infections
• Therapy with accept HAART regimen for greater than or equal to 6 months
• Viral load less than 50 copies RNA/ml plasma by RT-PCR for at least four months
• Viral load greater than 0.38 copies RNA/ml plasma by SCA assay or positive in the adapted Amplicor assay
• Current HAART with DHHS-approved regimen NRTI+PI, NRTI alone, NRTI+NNRTI.
• Willingness to take an additional antiretroviral to current regimen for 30 days.
• For patients to start lopinavir/ritonavir, willingness to reduce the dose of sildenafil and other co-administered medicines that may be affected by the addition of lopinavir/ritonavir during the course of therapy with lopinavir/ritonavir
• For patients to start efavirenz arm, willingness to take efavirenz and adjust other medications or supplements as necessary, and to be aware that efavirenz is contraindicated in pregnancy and that may result in false positive urine tests for THC
• For patients starting raltegravir, no prior history of rhabdomyolysis and no co-administration of agents which, in the opinion of the investigators, would cause rhabodomyolysis or myopathy.
• Patient must have primary care outside this protocol.

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)

• Gallego O, Ruiz L, Vallejo A, Ferrer E, Rubio A, Clotet B, Leal M, Soriano V; ERASE-3 Group. Changes in the rate of genotypic resistance to antiretroviral drugs in Spain. AIDS. 2001 Sep 28;15(14):1894-6. doi: 10.1097/00002030-200109280-00025.

  PMID: 11579258 BACKGROUND

• Lucas GM, Chaisson RE, Moore RD. Highly active antiretroviral therapy in a large urban clinic: risk factors for virologic failure and adverse drug reactions. Ann Intern Med. 1999 Jul 20;131(2):81-7. doi: 10.7326/0003-4819-131-2-199907200-00002.

  PMID: 10419445 BACKGROUND

• Adje C, Cheingsong R, Roels TH, Maurice C, Djomand G, Verbiest W, Hertogs K, Larder B, Monga B, Peeters M, Eholie S, Bissagene E, Coulibaly M, Respess R, Wiktor SZ, Chorba T, Nkengasong JN; UNAIDS HIV Drug Access Initiative, Abidjan, Cote d'Ivoire. High prevalence of genotypic and phenotypic HIV-1 drug-resistant strains among patients receiving antiretroviral therapy in Abidjan, Cote d'Ivoire. J Acquir Immune Defic Syndr. 2001 Apr 15;26(5):501-6. doi: 10.1097/00126334-200104150-00018.

  PMID: 11391173 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 Officials

• Frank Maldarelli, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 9, 2002
• First Posted: August 12, 2002
• Study Start: July 26, 2002
• Study Completion: February 7, 2013
• Last Updated: October 21, 2019

Record last verified: 2013-02-07

Locations

US (1)