A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00005764
• Date of registration: 30/05/2000
• Prospective Registration: No
• Primary sponsor: Glaxo Wellcome
• Public title: A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
• Scientific title: Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL)
• Date of first enrolment: May 2000
• Target sample size: 100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00005764
• Study type: Interventional
• Study design: Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria

Patients may be eligible for this study if they:

- Are HIV-positive.

- Are at least 18 years old.

- Agree not to have intercourse 2 weeks before, during, and 2 weeks after study or
agree to use effective methods of birth control.

- Have had HIV-1 RNA levels less than 400 copies/ml on the 2 most recent measurements.

- Have at least 1 of the following situations:

- (a) at least 1 of the following: (1) decrease in facial fat, (2) decrease in fat in
lower limbs, or (3) decrease in fat in buttocks area; or

- (b) an increase in lactate level greater than 2.2 mmol/L at the screening visit plus
at least 1 of the following: (1) decrease in facial fat, (2) decrease in fat in lower
limbs, or (3) decrease in fat in the buttocks area; or

- (c) an increase in lactate level greater than 2.2 mmol/L at screening visit plus at
least 2 of the following: (1) shortness of breath, (2) weakness, (3) fast heartbeat,
(4) recent weight loss (10 lbs. within the past 2 months), (5) pain and/or bloating
in the abdomen, (6) nausea and/or vomiting and/or lack of appetite; or

- (d) lactate level greater than 3.2 mmol/L at the screening visit.

- Are able to read at a sixth-grade level.

- Have taken d4T consistently for the 6 months before entering study.

Exclusion Criteria

Patients will not be eligible for this study if they:

- Have diabetes or kidney failure.

- Have any condition that makes them unable to participate in this study.

- Are unable to take medications by mouth.

- Have serious medical conditions, such as congestive heart failure or other heart
disease, which would affect the safety of the patient.

- Are taking or have taken abacavir plus Retrovir or Combivir.

- Are pregnant or breast-feeding.

- Are enrolled in other clinical studies.

- Have had a reaction to or are unable to take abacavir and have taken Retrovir in the
past.

- Have taken hydroxyurea within the past 3 days or plan to take this drug during the
study.

- Have had chemotherapy or radiation therapy within 4 weeks prior to screening visit
(except for local treatment for Kaposi's sarcoma) or plan to have such treatment
during the study.

- Have taken drugs that affect the immune system, such as systemic corticosteroids,
interleukins, vaccines, or interferons, within 4 weeks prior to the screening visit.

- Have had an HIV vaccine within 3 months of the screening visit.

- Have taken recombinant Human Growth Hormone (r-hGH), megestrol acetate, medicines
containing oxandrolone, oxymetholone, nandrolone, DHEA, or other testosterone
derivatives, or glucocorticoids or other systemic steroids (except inhaled and
topical steroids) in the last 4 months or plan to take these drugs during the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Lipodystrophy

Intervention(s)

Drug: Abacavir sulfate

Drug: Lamivudine/Zidovudine

Drug: Lamivudine

Secondary ID(s)

ESS40010

238T

Source(s) of Monetary Support

Please refer to primary and secondary sponsors