Clinical epidemiology of Herpes Simplex Virus type two and the impact of interventions against sexually transmitted infections to reduce human immunodeficiency virus incidence in high risk women from gold mining communities in Tanzania

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN35385041

Enrollment

1305

Registered

2005-07-22

Start date

2003-10-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human immunodeficiency virus (HIV) Infections and Infestations Unspecified human immunodeficiency virus [HIV] disease

Interventions

A double-blind, randomised, placebo-controlled trial of HSV-2 suppressive therapy with aciclovir 400 mg twice a day (bd), as a strategy to reduce HIV incidence, HSV-2 and HIV viral shedding. The trial

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Aged 16 to 35 years 2. HSV-2 seropositive 3. Not planning to leave study sites within next 24 months 4. No history of epilepsy 5. Able to understand aims and procedures of trial

Exclusion criteria

Exclusion criteria: 1. Pregnant or planning pregnancy within next 24 months 2. HSV-2 seronegative or indeterminate 3. Breastfeeding at time of enrolment 4. History of epilepsy 5. Temporary visitor in study sites 6. Unable to give informed consent

Design outcomes

Primary

Measure	Time frame
HIV acquisition study: 1. HIV incidence by treatment arm 2. Frequency of genital ulceration by treatment arm 3. Adherence to therapy HIV-positive women at enrolment: 1. Prevalence and quantity (log copies/ml) of cervico-vaginal HIV-1 RNA shedding by treatment arm 2. Plasma viral load by treatment arm 3. Prevalence and quantity of cervico-vaginal proviral HIV-1 DNA shedding 4. Prevalence and quantity of cervico-vaginal HSV-2 DNA shedding 5. Adherence to therapy	—

Measure

Time frame

HIV acquisition study: 1. HIV incidence by treatment arm 2. Frequency of genital ulceration by treatment arm 3. Adherence to therapy HIV-positive women at enrolment: 1. Prevalence and quantity (log copies/ml) of cervico-vaginal HIV-1 RNA shedding by treatment arm 2. Plasma viral load by treatment arm 3. Prevalence and quantity of cervico-vaginal proviral HIV-1 DNA shedding 4. Prevalence and quantity of cervico-vaginal HSV-2 DNA shedding 5. Adherence to therapy

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

Tanzania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 5, 2026