Effectiveness of Acyclovir in Suppressing HIV Viral Load in Women Coinfected With HIV and Herpes Simplex Virus Type 2 (HSV-2)

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine whether acyclovir is effective in suppressing HIV viral load in women infected with both HIV-1 and herpes simplex virus type 2 (HSV-2) who are starting HIV treatment for the first time.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Comprehensive International Program of Research on AIDS
• Treatments: Acyclovir

Criteria

Inclusion Criteria:

• HIV-1 infected

• HSV-2 infected

• Initiating HAART per Peruvian guidelines for the first time at study entry

• CD4 count less than 200 cells/mm3 OR CD4 count less than 350 cells/mm3 AND viral load greater than 55,000 copies/ml within 30 days prior to study entry

• Does not intend to move outside of greater metropolitan Lima, Peru area for the duration of the study

• Willing to follow all study requirements

• Willing to provide written informed consent

Exclusion Criteria:

• Prior HAART

• History of adverse reaction to acyclovir, famciclovir, or valacyclovir

• Unwilling to take acyclovir, famciclovir, or valacyclovir

• History of seizures

• Renal insufficiency, defined as serum creatinine greater than 2 mg/dl or a creatinine clearance less than 50 ml/min

• Treatment for a serious medical condition 14 days prior to study entry. Patients with chronic, acute, or recurrent opportunistic infections (OIs) who have completed therapy and are clinically stable on therapy for at least 14 days prior to study entry are not excluded.

• Clinically unstable and untreated OIs or tumors within 14 days prior to study entry. More information on this criterion can be found in the protocol.

• Clinically unstable and untreated bacterial sexually transmitted diseases (STDs) within 14 days prior to study entry. More information on this criterion can be found in the protocol.

• Radiation therapy or systemic chemotherapy within 45 days prior to study entry. Participants who underwent systemic chemotherapy for the treatment of Kaposi's sarcoma (KS) if it was completed prior to study entry are not excluded.

• Any immunomodulator, HIV vaccine, or other investigational therapy within 30 days prior to study entry. Patients who received a tapering course of corticosteroids as acute therapy for Pneumocystis carinii pneumonia (PCP) or are receiving inhaled or nasal fluticasone are not excluded.

• Current drug or alcohol use that, in the investigator's opinion, may interfere with the study

• Vomiting or inability to swallow medications

• Involuntarily incarcerated in a correctional facility, prison, or jail or being detained for the treatment of either a psychiatric or infectious disease

• Grade 2 or 3 high-grade cervical dysplasia and cervical neoplasia within 6 months prior to study entry

• Any other condition that, in the investigator's opinion, may interfere with the study

• Pregnancy